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National Registry of Assisted Reproductive Technology (ART) Clinics and Banks in India

This document provides instructions for clinics and banks to register with the National Registry of Assisted Reproductive Technology in India. It includes a pre-enrollment form seeking details about the clinic or bank name, address, contact information, and type of registration. For clinics, it lists the procedures performed and responsibilities. For banks, it describes responsibilities like recruiting donors and surrogates, and processing and storing gametes and embryos. Clinics must provide information on infrastructure, staff, and procedures to be registered.

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Sadhiq Syed
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0% found this document useful (0 votes)
71 views

National Registry of Assisted Reproductive Technology (ART) Clinics and Banks in India

This document provides instructions for clinics and banks to register with the National Registry of Assisted Reproductive Technology in India. It includes a pre-enrollment form seeking details about the clinic or bank name, address, contact information, and type of registration. For clinics, it lists the procedures performed and responsibilities. For banks, it describes responsibilities like recruiting donors and surrogates, and processing and storing gametes and embryos. Clinics must provide information on infrastructure, staff, and procedures to be registered.

Uploaded by

Sadhiq Syed
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 32

National Registry of Assisted Reproductive Technology (ART)

Clinics and Banks in India


Indian Council of Medical Research

Pre-Enrollment Form
For the registration under “National Registry of Assisted Reproductive Technology (ART) Clinics
and Banks in India”, Please fill the complete details in the table given below:

1. Name of the ART Clinic or ART Bank :

2. Name of the Director of the ART


Clinic/Hospital/Institution or ART Bank :
3. Name of the In-charge of ART Clinic or
ART Bank :

4. Full Postal Address of ART Clinic or ART


Bank (including City, State and Pin code) :

5. Contact Details (Tel No. with STD code,


Mob No. and Fax No.)`: Phone : ...............................................

Mobile : ...............................................

Fax : ...............................................
6. Email address of In-charge :

7. Website address (if any) :

8. Do you wish to register your clinic as an


ART clinic or ART bank?
(If you have both, kindly indicate whether you want
to register your unit as an ART Clinic or ART
Bank?)*

9. Do you have more than one ART Clinic or


Bank at same or different places
performing various ART procedures as
per the announcement? (Yes/No)
10. If Yes, Please send the full details in
above mentioned format of the other ART
Clinics or ART Banks.

Signature: .......................................................
Name: .................................................
(Director/ In-charge of the Clinic or Bank with seal)

* According to the draft ART (Regulation) Bill, ART clinic and ART bank have to be two separate independent institution
and should be registered independently with different address, identity and organizational structure .

Page 1 of 32
ART Clinic: “Assisted Reproductive Technology Clinic”, means any premises used for procedures
related to Assisted Reproductive Technology.

The following are the procedures are being followed by the ART Clinics:

• Artificial Insemination with Husband’s Semen (AIH)


• Artificial Insemination with Donor Semen (AID)
• Intra-uterine Insemination using Husband Semen (IUI-H)
• Intra-uterine Insemination using Donor Semen (IUI-D)
• In vitro Fertilization-Embryo Transfer (IVF-ET)
• Commercial Surrogacy
• Altruistic Surrogacy
• Gamete Intrafallopian Tube Transfer (GIFT)
• Intra-cytoplasmic Sperm Injection (ICSI)
• Physiological Intra-cytoplasmic Sperm Injection (PICSI)
• Intra-cytoplasmic Morphologically Selected Sperm Injection (IMSI)
• Round Spermatid Nucleus Injection (ROSNI)
• Elongated Spermatid Injection (ELSI)
• Percutaneous Epididymal Sperm Aspiration (PESA)
• Microsurgical Epididymal Sperm Aspiration (MESA)
• Testicular Sperm Aspiration (TESA)
• Testicular Sperm Extraction (TESE)
• Pre-implantation Genetic Diagnosis (PGD)
• Pre-implantation Genetic Screening (PGS)
• Blastocyst Separation Technique
• Endometrial Receptivity Array
• Time Lapse Imaging
• Processing or storage of gametes (sperm and oocyte) and or embryos of infertile patient

ART Banks: “ART Banks”, means an organisation that is set up to supply sperm/semen,
oocytes/oocyte donors and surrogate mothers to Assisted Reproductive Technology
Clinics or their patients.

The following are the responsibilities of the ART Banks:

(i) Advertising for sperm/semen and oocytes donors.


(ii) Clinical and laboratory examination of the donors.
(iii) Processing and cryopreservation of the sperm.
(iv) Ovarian stimulation, ovum pickup and cryopreservation of the oocytes.
(v) Advertising for surrogate mothers and clinical and laboratory examination of the surrogate mother.
(vi) Undertaking and maintaining all agreements of donors, surrogate mothers and of infertile couples
coming for donors and for hiring surrogate mothers.

Note: If ART Bank then do not proceed further, a separate proforma will be sent for ART Bank.

Page 2 of 32
Indian Council of Medical Research

National Registry of Assisted Reproductive Technology (ART) Clinics


and Banks in India

Proforma for
Infrastructure Facilities, Trained Manpower Available and
Procedures being undertaken at ART Clinic

SECTION- I (GENERAL INFORMATION)

Please follow the instructions given in the Instruction Manual while filling the
proforma and use capital letters only.

Name of the ART Clinic: __________________________________________________________

Name of the In-charge of the ART Clinic: ____________________________________________

Name of the Director of the ART Clinic/Hospital/Institution: _______________________________


_____________________________________________________________________________

Address of ART clinic: ___________________________________________________________

______________________________________________ City: __________________________

District: _____________________ State: ____________________ Pin Code:

Telephone No. (with STD Code) (ART Clinic only): ______________________________________

Mobile No. of Director (ART Clinic/Hospital/Institution): ___________________________________

Mobile No. of In-charge (ART Clinic):________________________________________________

Fax No. (ART Clinic only): ________________________________________________________

E-mail (In-charge of the ART Clinic): _________________________________________________

Website: _____________________________________________________________________

(Please do not fill this type of Boxes “ ”, to be filled by ICMR)

1. Card No.

(Signature & Seal of In-Charge of the ART Clinic) Page 3 of 32


2. State: …………………………………………………..
(Note: Please write the name of your State in the space provided above)

3. Enrollment No.

4. Date of filling the form -


5. Whether your ART Clinic is
1. National 2. International
(Note: If your ART clinic is National, then skip to Question No. 8)

6. If the ART Clinic is international, then please mention whether the head clinic or
main clinic is located in
1. India 2. Outside India
7. If head clinic is outside India, then please specify whether the Director/Owner is
1. Non Resident Indian 2. Foreigner
8. Status of your ART Clinic
1. Government 2. Semi-Government 3. Private
4. Charitable Trust 5. NGO 6. Public Sector Undertaking
7. Any other, please specify……………………………………………………………………..
9. Whether your ART Clinic is Allopathic
1. Yes 2. No
(Note: If your ART clinic is Allopathic, then skip to Question No. 11)

10. If No, then please specify …………………………………………………...…………..…


11. Date of establishment of your ART Clinic
12. Whether your ART Clinic is registered under the following Acts/Authorities (Please provide
details)

(1) (2) (3) (4) (5) (6) (7) (8)


State of
Validity
Registration
If Yes, then please of
authority If No, then please
S. Name of the 1. Yes specify the Date of Reg. Registr
(write in specify reason in
No. authority 2. No Registration (DD-MM-YY) ation
space space provided
Number (in
provided
years)
below)
1. Accreditation with ………………………
International ………….............. ..………….… ………………………
Organization for ………………………
Standardization
(ISO) ……………..

2. Medical ………………………
Termination of ………….............. ..……………. ………………………
Pregnancy (MTP) ………………………
Act
……………..

3. Pre-Conception ………………………
and Pre-Natal ………….............. ..……………. ………………………
Diagnostic ………………………
Techniques
(PCPNDT) Act …………….

(Signature & Seal of In-Charge of the ART Clinic) Page 4 of 32


4. Bio-Medical ………………………
Waste ………….............. ..…………… ………………………
(Management and ………………………
Handling) Rules
……………

5. Clinical ………………………
Establishment Act ………….............. ..……..……. ………………………
………………………
……………

6. NOC from Fire ………………………


Safety ………….............. …………...... ………………………
Department ………………………
……………..

13. Whether your ART clinic is registered with any other authority in addition to above
1. Yes 2. No
(Note: If No, then skip to question no. 15)

14. If yes, then please give the details


(1) (2) (3) (4) (5) (6)
Whether
authority is State of Registration
S. 1. Central Govt.
Date of Reg.
Name of the authority Registration Number authority (write in
No. 2. State Govt. (DD-MM-YY)
space provided below)
3. Both
4. Any other

1. ……………………
…………..................... ..……… ………..
……………………
…………….

2. ……………………
…………..................... ..……… ………..
……………………
…………….

3. ……………………
…………..................... ..……… ………..
……………………
……………

4. ……………………
…………..................... ..……… ………..
……………………
……………

5. ……………………
…………..................... ..……… ………..
……………………
……………

Page 5 of 32
(Signature & Seal of In-Charge of the ART Clinic)
15. Whether your ART clinic is within a hospital/Institution
1. Yes 2. No
(Note: If No, then skip to question no. 17)

16. If Yes, then please provide the Name and Address of the hospital/Institution

……………………………………………………………………………………………………….

……………………………………………………………………………………………………….

……………………………………………………………………………………………………….

17. Whether your hospital/Institution is having more than one ART clinics within the
country
1. Yes 2. No
(Note: If No, then skip to question no. 22)

18. If Yes, then please indicate whether your ART clinic is


1. Head Clinic 2. Sub-clinic/Branch
(Note: If Sub-clinic/Branch then skip to question no. 21.)

19. If head clinic, please specify total number of sub-clinics/branches under head
clinic
20. Please give the name, address and contact details of the sub-clinics/branches which are
situated in different regions of the country under the head clinic

(1) (2) (3) (4) (5)


Enrollment No.
S. State
Name of (write in space Address & contact details (In-charge only) of sub- (If already obtained from
No. provided below) clinics/branches National Registry of
sub-clinic/branch
ART Clinics and Banks
in India of ICMR)

1. ………………… ..……….…… ………………………………………………...


………………… ………………………………………………...
………………… ………………………………………………...
……………… … Mob: …………………………………………...
Email: ………………………………………….

2. ………………… ..……………. ………………………………………………...


………………… ……………………………………………...…
………………… ………………………………………………...
………………… Mob: …………………………………………...
Email: ………………………………………….

Page 6 of 32
(Signature & Seal of In-Charge of the ART Clinic)
3. ………………… ..………..….. ………………………………………………...
………………… ………………………………………………...
………………… ………………………………………………...
………………… Mob: …………………………………………...
Email: ………………………………………….

4. ………………… ..…………… ………………………………………………...


………………… ………………………………………………...
………………… ………………………………………………...
………………… Mob: …………………………………………...
Email: ………………………………………….

5. ………………… ..……….…… ………………………………………………...


………………… ………………………………………………...
………………… ………………………………………………...
………………… Mob: …………………………………………...
Email: ………………………………………….

(Note: If more than five sub-clinics/branches, then please add separate sheets accordingly)

21. If sub-clinic/branch, please provide the following details of the Head clinic

a) Enrollment no. issued by National Registry of ART clinics and Banks in India of
ICMR to Head clinic

b) Address of Head clinic………………………………………………………………………..


………………………………………………………………………………………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………
c) Mobile no. of In-charge

(Signature & Seal of In-Charge of the ART Clinic) Page 7 of 32


SECTION - II (MANPOWER)

Details of the Staff Available at your ART Clinic:


22. Whether your ART Clinic/hospital has Director
1. Yes 2. No

23. If yes, give the details of qualification of Director


Qualification
Please indicate the highest qualification/degree

(1) (2) (3) (4) (5)


Sl. No. Name of the degree Area/Discipline Whether Experience
1. Ph.D./DM/M.Ch. 1. Medicine 1. Regular in Infertility
2. PG/MD/MS/DNB 2. Life Sciences 2. Part-time /ART
3. PG Diploma 3. Any other
(in yrs)
4. Diploma
5. Graduate/MBBS
6. Any other

1. ……………………………….. ……………………….

(Note: Please enter the code in the given box and write degree in the space given above.)

24. Whether your ART Clinic has In-charge


1. Yes 2. No
(Note: In-charge of the ART clinic should be a trained gynecologist having appropriate degree as per ICMR
ART guidelines and should conduct & supervise all the ART procedures at the ART clinic.)

25. If yes, give the details of qualification of the In-charge


Qualification
Please indicate the highest qualification/degree

(1) (2) (3) (4) (5)


Sl. No. Name of the degree Area/Discipline Whether Experience
1. DM/M.Ch. 1. Obst. & Gynecology 1. Regular in ART
2. MD/MS/DNB 2. Any other 2. Part-time (in yrs)
3. PG Diploma
4. Any other

1. ……………………………..... …...…………………

(Note: Please enter the code in the given box and write degree in the space given above.)

26. Whether your ART Clinic has more than one Gynecologist
1. Yes 2. No
27. If yes, please indicate the total number of Gynecologists

28. Give the details of qualification of Gynecologist


Qualification
Please indicate the highest qualification/degree

(Signature & Seal of In-Charge of the ART Clinic) Page 8 of 32


(1) (2) (3) (4) (5)
Sl. No. Name of the degree Area/Discipline Whether Experience
1. DM/M.Ch. 1. Obst. & Gynecology 1. Regular in ART
2. MD/MS/DNB 2. Any other 2. Part-time (in yrs)
3. PG Diploma
4. Any other

1. ………………………..………. …………..……….…

2. ……………………………….. ………………..…….

3. ……………………………….. ……………………….

Note: (i) Please enter the code in the given box and write degree in the space given above.
(ii) If more than three, then please add separate sheets accordingly.

29. Whether your ART Clinic has Andrologist


1. Yes 2. No

30. If yes, then please indicate the total number of Andrologists


31. Give the details of qualification of Andrologist
Qualification
If more than one Andrologist then enter the information below from Serial no. 2 onwards
otherwise leave blank.
Please indicate the highest qualification/degree

(1) (2) (3) (4) (5)


Sl. No. Name of the degree Area/Discipline Whether Experience
1. Ph.D./DM/M.Ch. 1. Urology 1. Regular in Andrology
2. MD/MS/DNB 2. General Surgery 2. Part-time (in yrs)
3. PG Diploma 3. Any other
4. Any other

1. …………………………….… ………………….......

2. ………………………………. ……………………....

3. ………………………………. ………………............

Note: (i) Please enter the code in the given box and write degree in the space given above.
(ii) If more than three, then please add separate sheets accordingly.

32. Whether your ART Clinic has Clinical Embryologist


1. Yes 2. No

33. If yes, then please indicate the total number of Clinical Embryologists

(Signature & Seal of In-Charge of the ART Clinic) Page 9 of 32


34. Give the details of qualification of Clinical Embryologist
Qualification
If more than one Clinical Embryologist then enter the information below from Serial no. 2 onwards
otherwise leave blank.
Please indicate the highest qualification/degree

(1) (2) (3) (4) (5)


Sl. No. Name of the degree Area/Discipline Whether Experience in
1. Ph.D./DM/M.Ch. 1. Medicine 1. Regular Embryology
2. PG/MD/MS/DNB/M.V.Sc. 2. Life Sciences 2. Part-time (in yrs)
3. PG Diploma 3. Veterinary Sciences
4. Any other
4. Diploma
5. MBBS/B.V.Sc./B.Sc.
6. Any other

1. …………………………..….. ...…………..………..

2. ………………………….…… ...……..……………..

3. ……………………………….. ….....………………..

Note: (i) Please enter the code in the given box and write degree in the space given above.
(ii) If more than three, then please add separate sheets accordingly.

35. Whether your ART Clinic has Counselor


1. Yes 2. No
36. If yes, then please indicate the total number of Counselors

37. Give the details of qualification of Counselor


Qualification
If more than one Counselor then enter the information below from Serial no. 2 onwards otherwise
leave blank.
Please indicate the highest qualification/degree

(1) (2) (3) (4) (5)


Sl. No. Name of the degree Area/Discipline Whether Experience in
1. Ph.D./DM/M.Ch. 1. Social Sciences 1. Regular Counseling in
2. PG/MD/MS/DNB 2. Psychology 2. Part-time ART
3. PG Diploma 3. Life Sciences (in yrs)
4. Medicine
4. Diploma
5. Any other
5. Graduate/MBBS
6. Any other

1. ………………………..……… ………………….….

2. ……………………………….. …………….............

3. ……………………………….. ……………………..

(Note: Please enter the code in the given box and write degree in the space given above.)

(Signature & Seal of In-Charge of the ART Clinic) Page 10 of 32


(Note: A member of the staff of an ART clinic who is not engaged in any other full-time activity in the ART
clinic can act as a counselor. Counselor has to be independent.)

38. Number of staff members other than the specified above employed in your ART
Clinic
39. Please provide the details of the other staff members in the table given below:
(1) (2) (3) (4) (5) (6)
Sl. No Name of the Post Qualification Area/Discipline Whether No. of
1. Doctorate 1. Medicine 1. Regular Post
2. Post Graduate 2. Nursing 2. Part-time
3. Graduate 3. Life Sciences
4. Diploma 4. Social Sciences
5. Under Graduate 5. Psychology
6. Any other 6. Any other

1. ……………………...... ………….................. …………..................


………….....… ……………..…. ………………...

2. ………………….......... ………….................. …………..................


………….....… ……………..…. ………………….

3. ……………………...... ………….................. …………..................


………….....… ……………..…. ………………….

4. ………………….......... ………….................. …………..................


………….....… ……………..…. …………………

5. ………………….......... ………….................. …………..................


………….....… ……………..…. …………………

6. ………………….......... ………….................. …………..................


………….....… ……………..…. ………………..

7. ………………….......... ………….................. …………..................


………….....… ……………..…. ………………..

8. ………………….......... ………….................. …………..................


………….....… ……………..…. ………………..

9. ………………….......... ………….................. …………..................


………….....… ……………..…. ………………..

10. ………………….......... ………….................. …………..................


………….....… ……………..…. ………………..

(Note: If more than 10, then please add separate sheets accordingly.)

(Signature & Seal of In-Charge of the ART Clinic) Page 11 of 32


SECTION - III (INFRASTRUCTURE)

Infrastructure Facilities Available at ART Clinic


40. Does your ART clinic has Non Sterile Area
1. Yes 2. No
41. If yes, whether the Non Sterile Area is provided with
1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)

a. Reception area

b. Waiting room for patients

c. Examination room with privacy

d. A general purpose clinical laboratory

e. Store room

f. Record room

g. Autoclave room

h. Semen collection room

42. Whether your ART clinic has Provision for vermin proofing
1. Yes 2. No

43. Does your ART clinic has Sterile Area


1. Yes 2. No

44. If yes, whether Sterile Area is provided with


1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly, In case of not applicable then enter 9 in the box)

a. Area for changing into sterile garments

b. Semen processing laboratory (as per GLP)

c. Operation Theatre well equipped for carrying out surgical endoscopy,


transvaginal ovum pick-up, Embryo transfer and should be equipped for
Emergency resuscitative procedures
d. Embryology Laboratory Complex

e. Operating table for carrying out the procedures

f. Whether the sterile area is air conditioned with fresh air filtered through
an appropriate filter systems along with ambient temperature of 22oC – 25oC
(Air Handling Unit)

g. Pre and Post operation areas

(Signature & Seal of In-Charge of the ART Clinic) Page 12 of 32


h. Bio medical waste disposal system
i. Toilet room for the patients
j. Lift facility
k. Fire exit area

45. Whether Embryology Laboratory Complex is provided with


1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly, In case of not applicable then enter 9 in the box)

a. Facility for control of temperature & humidity (Air handling unit)

b. Filtered air with an appropriate number of air exchanges per hour

c. Wall and floors are composed of materials that can be easily washed and
disinfected

d. A laminar flow bench with a thermostatically controlled heating plate

e. A IVF grade Stereo Microscope preferably with CCD camera and


recording software
f. A routine high powered Trinocular light microscope ( IVF grade and
preferably with CCD camera and recording software)

g. A high resolution inverted microscope with phase contrast or Hoffman


Optics (with standard IVF grade objective), preferably with facilities for
video recording

h. A micromanipulator (if ICSI is done)

i. A CO2 incubator, preferably with a back up

j. A hot air oven

k. A laboratory centrifuge

l. Equipment for freezing embryos

m. Liquid nitrogen cans for


I. IVF
II. Infected samples
n. A pharmaceutical refrigerator
o. Heating plates
p. Test tube heater
q. Heating blocks
r. Alloy blocks/ Plates
s. Biometrics (to restrict the entry)

(Signature & Seal of In-Charge of the ART Clinic) Page 13 of 32


t. Temperature
u. CO2 analyzer
v. Volatile Organic Compounds (VOCs) Filtration system
w. IVF Software
x. Ovum Pick-Up (OPU) Pump
y. CCD Monitoring System
z. IVF Witness System
aa. Auto-analyzer for Sperm Function Test
bb. Computer Assisted Semen Analysis (CASA)
cc. CO2 and Triple gas Manifold
dd. Makler Chamber
ee. Cryofreezer
ff. Whether you have separate incubators for
I. Oocytes
II. Sperms
gg. To avoid mixing of gametes or embryos whether proper labeling of patient’s
name is being done on
I. All tubes
II. Dishes
III. Transfer pipettes

hh. Whether all used pipettes are immediately discarded

46. Whether your ART Clinic has got hormone assay facility
1. Yes 2. No
(Note: If No, then skip to Question No. 48)
47. If yes, whether performing following hormone and other assay at your clinic
1. Yes 2.No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)

a. FSH
b. LH
c. Prolactin
d. hCG
e. TSH
f. Estradiol
g. Progesterone

Page 14 of 32
(Signature & Seal of In-Charge of the ART Clinic)
h. Testosterone
i. DHEA
j. HIV
k. Hepatitis B
l. HCV
m. VDRL
n. AMH

48. Whether outsourcing from specialty laboratory


1. Yes 2. No

49. If yes, whether outsourcing from


1. Single Laboratory 2. Multiple Laboratories
(Note: If Single Laboratory, then skip to Question No. 51)

50. If multiple laboratories, please specify the number of laboratories


51. Name and distance (in kms) of the outsourcing Laboratories from your ART Clinic
a. (i) Name……………………………………………………………………………..

(ii) Distance

b. (i) Name……………………………………………………………………………..

(ii) Distance

c. (i) Name……………………………………………………………………………..

(ii) Distance

52. Whether the result of Estradiol test is used for determining the dose of drug
required for induction of ovulation
1. Yes 2. No

53. Do you have Microbiology Lab


1. Yes 2. No
(Note: If Yes, then skip to Question No. 56)

54. If no, whether outsourcing from specialty laboratory


1. Yes 2. No
55. If yes, distance (in kms) between your ART clinic and specialty laboratory
56. If you have microbiology laboratory then please indicate whether it can carryout
rapid test for any infection
1. Yes 2. No

57. If no, specify the reason …………………………………………………................


58. Do you have Clinical Chemistry Laboratory
1. Yes 2. No
(Note: If Yes, then skip to Question No. 61)

(Signature & Seal of In-Charge of the ART Clinic) Page 15 of 32


59. If no, whether outsourcing from specialty laboratory
1. Yes 2. No
60. If yes, distance (in kms) between your ART clinic and specialty laboratory
61. Do you have facility for carrying out Histopathological Studies
1. Yes 2. No
(Note: If Yes, then skip to Question No. 64)

62. If no, whether outsourcing from specialty laboratory


1. Yes 2. No
63. If yes, distance (in kms) between your ART clinic and specialty laboratory

64. Whether the following are periodically checked for microbial contamination using standard
techniques
1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)
a. Laminar flow hoods
b. Laboratory tables
c. Incubators
d. Lab, OT walls and floor

65. Whether records of such checks are properly maintained at the clinic
1. Yes 2. No

66. If no, specify the reason …………………………………………………………

67. Are you performing the following for maintenance of the laboratories:
1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)
a. Maintaining in writing, standard operating manuals
b. Daily Log Book for recording the following in the incubator
I. Temperature
II. Humidity
III. CO2 content
c. Record Book for calibration of all equipments
d. Are you performing the following in your laboratories:
I. Volatile organic compounds (VOCs)
II. Particle count

68. Whether quality consumables like disposable plastic ware are procured from
reliable sources in the laboratory
1. Yes 2. No

69. Whether the plastic ware used are non-toxic to the embryos/ gametes
1. Yes 2. No

(Signature & Seal of In-Charge of the ART Clinic) Page 16 of 32


70. Whether the Culture Media used is commercial
1. Yes 2. No
(Note: If No, then skip to Question No. 72)

71. If Yes, please indicate whether the composition of media is known to the clinical
embryologist
1. Yes 2. No

72. If Culture Media is prepared at centre then please indicate whether Culture Media
tested for the following regularly at the Clinic
1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)

a. Sterility

b. Endotoxins

c. Osmolality

d. pH

e. Nucleic Acid Amplification Testing

f. Mouse Embryo Assay Testing

g. Limulus Amebocyte Lysate Testing

h. Sterility Assurance Level Testing

i. Hepatitis-B Surface Antigen

j. Hepatitis-C RNA

73. Whether an appropriate provision for back-up power supply available at our ART
clinic
[

1. Yes 2. No
(Note: If No, then skip to Question No. 75)

74. If yes then which of the following are being used


1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)

a. UPS System

b. Captive power generative system

c. Both

d. Other, please specify ……………………………………………......

75. If No, please specify the reasons………………………………………….

(Signature & Seal of In-Charge of the ART Clinic) Page 17 of 32


SECTION - IV (PROCEDURES)
76. Indicate which of the following ART procedures are being routinely carried out at your
ART Clinic
1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)

a. Artificial Insemination with Husband Semen (AIH)

b. Artificial Insemination with Donor Semen (AID)

c. Intra-uterine Insemination using Husband Semen (IUI-H)

d. Intra-uterine Insemination using Donor Semen (IUI-D)

e. In vitro Fertilization-Embryo Transfer (IVF-ET)

f. Commercial Surrogacy

g. Altruistic Surrogacy

h. Gamete Intrafallopian Tube Transfer (GIFT)

i. Intra-cytoplasmic Sperm Injection (ICSI)

j. Physiological Intra-cytoplasmic Sperm Injection (PICSI)

k. Intra-cytoplasmic Morphologically Selected Sperm Injection (IMSI)

l. Round Spermatid Nucleus Injection (ROSNI)

m. Elongated Spermatid Injection (ELSI)

n. Percutaneous Epididymal Sperm Aspiration (PESA)

o. Microsurgical Epididymal Sperm Aspiration (MESA)

p. Testicular Sperm Aspiration (TESA)

q. Testicular Sperm Extraction (TESE)

r. Pre-implantation Genetic Diagnosis (PGD)

s. Pre-implantation Genetic Screening (PGS)

t. Blastocyst Separation Technique

u. Endometrial Receptivity Array

v. Time Lapse Imaging

w. Processing or storage of gametes (sperm & oocyte) and or embryos


of infertile patient
x. Any other procedure, please specify…………………………………………….

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77. Whether you have any facility for cryopreservation of infertile patients
sperm/oocyte and or embryo
1. Yes 2. No
78. If yes, then please provide the details
1. Yes 2. No
a. Freezing of sperm
I. Sperm slow freezing
II. Sperm vitrification
b. Freezing of oocytes
I. Oocyte slow freezing
II. Oocyte vitrification

c. Freezing of zygotes
I. Zygotes slow freezing
II. Zygotes vitrification

d. Freezing of embryos
I. Day 2
II. Day 3
III. Day 4
IV. Day 5/6
e. Cryopreservation of ovarian tissue
f. Freezing of Testicular tissue
79. Kindly indicate the provision/facility available at your ART Clinic
1. Yes 2. No
(Note: Enter the code i.e. 1 or 2 in the boxes accordingly)

(I). Work-up
a. Diligent history taking

b. Counseling

(II). Male Factors


a. Treatment of oligozoospermia
b. (i) Detecting infection of the reproductive tract using appropriate diagnostic
test
(ii) If yes, please specify the procedure
1. Routine Test 2. Culture Test (antibiotic sensitivity test) 3. Both
c. Immunological test for infertility
d. Provision for semen collection in men with a vibrator or an Electroejaculator
in erectile dysfunction and ejaculatory problems

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e. Procedures for IUI
i). Wash and swim-up
ii). Density gradient
iii). Sperm recovered from post-coital specimen of urine in retrograde
ejaculation
f. Karyotyping

(III). Female Factors


a. Treatment of minor anatomical defects like imperforate hymen

b. Treatment of endometriosis after confirming its presence by diagnostic


laparoscopy
c. Induction of ovulation in anovulatory women with drugs such as Clomiphene
Citrate etc.
i) With adjuncts like bromocriptine, eltroxin, dexamethasone or
spironolactone

ii) Without adjuncts like bromocriptine, eltroxin, dexamethasone or


spironolactone

d. Please specify the drug being used routinely for ovulation induction
I. In IUI
i). Clomiphene Citrate (CC)

ii). Letrozole

iii). Gonadotrophins

iv). Gonadotrophins+Letrozole

v). Any other, please specify…………………………………………..


II. In IVF
i). Clomiphene Citrate (CC)

ii). Letrozole

iii). Gonadotrophins+Letrozole

iv). Agonist protocol

v). Antagonist protocol

vi). Any other, please specify………………………………………

e. Correcting endocrine disorders such as


I. Thyroid disorders

II. Hyperprolactinemia

f. (i) Detecting infection of the reproductive tract using appropriate diagnostic

(Signature & Seal of In-Charge of the ART Clinic) Page 20 of 32


test

(ii) If yes, please specify the procedure


1. Routine Test 2. Culture Test (antibiotic sensitivity test) 3. Both

g. Conservative surgery either through a

i). Laparoscopy

ii). Hysteroscopy

iii). Laparotomy

h. Combined medical-surgical therapy by a co-ordinated team, for example


in endometriosis

i. Assessment of follicular growth and ovulation by serial ultrasonography

j. Immunological tests for infertility

k. Tests for antibodies (IgG, IgA) against sperm antigen in cervical mucous

l. Assessment of follicular growth and ovulation by serial transvaginal


sonography (TVS)

m. Provision for extended treatment of infertility except for oocyte pick up

n. Karyotyping

o. Saline Sono Salpingography

p. Hysterosalpingogram (HSG)

(IV) Andrology
A. Basic
a. Basic investigations such as physical examination and semen analysis
(as per WHO method)
b. If not following WHO method for semen analysis then please specify the
other method being used …………………………………………..
c. Assessment of cell contaminants, debris and infection

d. Assessment of seminal plasma for


i). Viscosity

ii). Liquefaction
iii). Blood contamination

iv). Accessory gland markers

B. Advanced (sperm function test)

a. Sperm Function Test like hypo-osmotic swelling test (HOST)

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b. Assessment of the improvement of sperm motility potential with
pentoxifylline co-culture
c. Tests for sperm function and integrity such as acrosome reaction and
sperm-oocyte interaction in-vitro

80. Category of the ART Clinic


1. Primary 2. Secondary 3. Tertiary 4. Any other

81. Registration Number to be provided by ICMR.


a). Nationality: ………………………………………………………

b). State: …………………………………………………………….

c). Board (State/Central): ……………………………………....... .

d). Facility (ART Clinic/ART Bank): ………………………………

e). Multiple/Single: …………………………………………………

f). Category: ………………………………………………………..

g). Enrollment Number: …………………………………………….

DECLARATION

I hereby declare that the entries in this form and the additional particulars, if any,
furnished herewith are true to the best of my knowledge and belief.

Date: _____________ (Signature of In-charge of the ART Clinic)


Name: ………………………………………………………….
Designation with Seal: .…………………………………….

(Signature of Director of the ART Clinic/Hospital/Institute)


Name: ………………………………………………………….
Designation with Seal: .…………………………………….

(Signature & Seal of In-Charge of the ART Clinic) Page 22 of 32


Note: Kindly submit the following documents along with duly filled proforma:
1. Copies of duly attested (Self / In-charge of ART Clinic) highest degree only of Director, In-
charge, Gynaecologists, Andrologists, Clinical Embryologists and Counselors.

2. Experience certificate on the letter head of the Director or In-charge of the ART clinic where
the following staff members are presently employed

a) Director b) In-charge c) Gynaecologists

d) Andrologists e) Clinical embryologists f) Counselors

3. Copy of duly attested certificates of the following:

a) International Organization for Standardization (ISO)

b) Medical Termination of Pregnancy (MTP) Act

c) Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act

d) Bio-Medical Waste (Management and Handling) Rules

e) Clinical Establishment Act

f) NOC from Fire Safety Department etc. …………….

4. Enclosed documents should be properly labeled and number.

(Signature & Seal of In-Charge of the ART Clinic) Page 23 of 32


Indian Council of Medical Research

National Registry of Assisted Reproductive Technology (ART) Clinics


and Banks in India

Instruction Manual for Filling up the


Proforma for Infrastructure Facilities, Trained Manpower available
and Procedures being undertaken at ART Clinic

SECTION- I (GENERAL INFORMATION)

Please write the name of the ART clinic, name of the Director, In-charge and address,
telephone number, fax number, e-mail ID and website address of the ART clinic in capital letters
in the space provided. Kindly provide mobile numbers of the Director and In-charge of the ART
clinic in the space provided.

Please fill the code according to the instruction given in the manual starting from
Question no.1 and enter the proper code in dark boxes “ ” and other necessary information in
the space provided only in capital letters.

Note: Please do not fill dotted boxes “ ”.

1. Card No. will be given by ICMR (please do not fill the dotted boxes).

2. Write the Name of the State in the given space (please do not fill the dotted boxes).

3. Enrollment No. will be given by ICMR (please do not fill the dotted boxes).

4. Please fill the date of filling the form in the given boxes in DD/MM/YY format.

5. Fill in the given box ‘1’ for National, ‘2’ for International. In case ART clinic is National then
skip to Question no. 8 otherwise continue.

“National” means your clinic and/or branches of your ART Clinics are situated in any
city or state of India only.

“International” means your clinic and/or branches of your ART Clinics are situated in India
and other countries also.

6. If the ART Clinic is international, then please fill in the given box ‘1’ for India and ‘2’ for
Outside India.

7. If the Director/Owner is Non Resident Indian (NRI), then please fill ‘1’ and in case the
Director/Owner has a citizenship of country other than India then please fill ‘2’ for Foreigner
in the given box.

8. Fill in the given box ‘1’ for Government, ‘2’ for Semi-Government, ‘3’ for Private, ‘4’ for
Charitable Trust, ‘5’ for Non-Government Organization (NGO), ‘6’ for Public Sector

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Undertaking and ‘7’ for Any other and in case of Any other, please write the status in the
space provided.

9. Fill in the given box ‘1’ for Yes and ‘2’ for No. In case your ART clinic is Allopathic, then skip
to Question No. 11 otherwise continue.

10. If your ART clinic is not Allopathic then specify in space provided and do not fill the dotted
boxes.

11. Please fill the date of establishment of your ART Clinic in given boxes in DD/MM/YY format.

12. In case your ART Clinic is registered under the following Acts/Authorities specify in column
no. 2, then please write the following details such as

• In column 2 of the table: If your ART clinic is registered with the mentioned
Acts/authorities then reply in column 3, 4, 5, 6, 7 and 8 respectively.

• In column 3 of the table: Fill in the given box ‘1’ for Yes, ‘2’ for No.

• In column 4 of the table: In case your ART clinic is enrolled with respective
Acts/authorities then write the Registration number in the space provided.

• In column 5 of the table: Write the name of the state of Registration authority from
where your ART Clinic obtained this registration number in the space provided and do
not fill the dotted boxes.

• In column 6 of the table: Fill the date of registration when your ART Clinic was
registered under that Acts/authority in the given boxes in DD/MM/YY format.

• In column 7 of the table: Fill the Validity of Registration (in years) in given boxes.

• In column 8 of the table: In case your ART clinic is not registered with respective
Act/authority, then please specify reason in space provided and do not fill the dotted
boxes.

13. In case ART clinic is registered with any other authority in addition to specify
Acts/Authorities in Question no. 12, then fill ‘1’ for Yes and ‘2’ for No. If No, then skip to
Question no. 15 otherwise continue.

14. In case ART clinic is registered with any other authority in addition to specify
Acts/Authorities in Question no. 12, then

• In column 2 of the table: Write the name of the authority in the space provided and do
not fill the dotted boxes.

• In column 3 of the table: Fill in the given box ‘1’ for Central Govt., ‘2’ for State Govt., ‘3’
for Both and ‘4’ for Any Other.

• In column 4 of the table: Write the Registration number in the space provided.

• In column 5 of the table: Write the name of the State in the space provided from where
your ART Clinic obtained this registration number and do not fill the dotted boxes.

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• In column 6 of the table: Fill the date of registration when your ART Clinic was
registered under that authority in the given boxes in DD/MM/YY format.

15. Fill in the given box ‘1’ for Yes and ‘2’ for No. If your ART clinic is not within a
hospital/Institution, then skip to Question no. 17 otherwise continue.

16. In case your ART clinic is within a hospital/Institution, then specify the address of
hospital/Institution in space provided.

17. Fill in the given box ‘1’ for Yes and ‘2’ for No. In case your hospital/Institution is not having
more than one ART clinics within the country, then skip to Question no. 22, otherwise
continue.

18. Fill in the given box ‘1’ for Head Clinic/ Facility and ‘2’ for Sub-clinic/ Branch. In case ART
clinic is Sub-clinic/Branch, then skip to question no. 21, otherwise continue.

“Head Clinic” means central/main clinic coordinating the activities and also owns the
responsibility of all its branches or sub-clinics.

“Sub-Clinic” is a clinic though running independently but is under coordination of the head
clinic.

19. Specify total number of sub-clinics/branches under head clinic in given boxes.

20. Please give the name, address and contact details of the sub-clinics/branches which are
situated in different regions of the country under the head clinic, such as

• In column 2 of the table: Write the name of sub clinic/branch in the space provided.

• In column 3 of the table: Write the name of the state in space provided where sub-
clinics/branches is situated and do not fill the dotted boxes.

• In column 4 of the table: Write the address of sub-clinic/branch, mobile no. and email
address of only In-charge of sub-clinic/branch in the space provided.

• In column 5 of the table: Fill the enrollment no. in the given boxes if already obtained
from the National Registry of ART Clinics and Banks in India of ICMR.

Note: If you have more than five sub-clinics/branches, please attach the separate sheets
and fill accordingly.

21. If ART clinic is sub-clinic/branch then provide the following details of the Head clinic

a) Fill the enrollment no. issued by National Registry of ART clinics and Banks in India
of ICMR to Head clinic in given boxes.

b) Write the address (in capital letters) of Head clinic in space provided.

c) Fill the mobile no. of In-charge only in given boxes.

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SECTION - II (MANPOWER)

“Director” should be a senior person who has had considerable experience in all aspects
of ART. The director should be able to co-ordinate the activities of the rest of the team and
take care of staff administrative matters, stock keeping, finance, maintenance of patient
records, statutory requirements, and public relations as described in the ICMR ART
guidelines.

22. Fill in the given box ‘1’ for Yes and ‘2’ for No.

23. Give the following details of qualification of the Director:


• In column 2 of the table: Write the highest qualification/degree in the space provided
and also fill the proper code in the given box. The codes are :- ‘1’ for Ph.D./DM/M.Ch.,
‘2’ for PG/MD/MS/DNB, ‘3’ for PG Diploma, ‘4’ for Diploma, ‘5’ for Graduate/MBBS and
‘6’ for Any other. In case of “Any other”, please specify in the given space.

• In column 3 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Medicine, ‘2’ for Life Sciences and ‘3’ for Any other. In case of “Any
other”, please specify in the given space.

• In column 4 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 5 of the table: Fill the experience in infertility/ART (in yrs) in the given boxes.
In case, experience is in years and months then take round off value in years (e.g. if the
experience is more than & equal to 2 years 6 months then take round off value as 3
years and if value is less than 2 year 6 months then take round off value as 2 years).

“In-charge” means a person should be a trained gynecologist having appropriate degree as


per ICMR ART guidelines and should conduct & supervise all the ART procedures at the
ART clinic.

24. Fill in the given box ‘1’ for Yes and ‘2’ for No.

25. Give the following details of qualification of the In-charge:


• In column 2 of the table: Write the highest qualification/degree in the space provided
and also fill the proper code in the given box. The codes are :- ‘1’ for DM/M.Ch., ‘2’ for
MD/MS/DNB, ‘3’ for PG Diploma and ‘4’ for Any other. In case of “Any other”, please
specify in the given space.

• In column 3 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Obst. & Gynecologist and ‘2’ for Any other. In case of “Any other”,
please specify in the given space.

• In column 4 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 5 of the table: Fill the experience in area of ART (in yrs) in the given boxes.
In case, experience is in years and months then take round off value in years (e.g. if the
experience is more than & equal to 2 years 6 months then take round off value as 3
years and if value is less than 2 year 6 months then take round off value as 2 years).

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26. Fill in the given box ‘1’ for Yes and ‘2’ for No.

27. Fill the number of Gynecologists in the given boxes.

28. Please give the details of qualification of Gynecologist:

• In column 2 of the table: Write the highest Qualification/degree in the space provided
and also fill the proper code in the given box. The codes are :- ‘1’ for DM/M.Ch., ‘2’ for
MD/MS/DNB, ‘3’ for PG Diploma, ‘4’ for Any other. In case of “Any other”, please specify
in the given space.

• In column 3 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Obst. & Gynecologist and ‘2’ for Any other. In case of “Any other”,
please specify in the given space.

• In column 4 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 5 of the table: Fill the experience in the area of ART (in yrs) in the given
boxes. In case, experience is in years and months then take round off value in years
(e.g. if the experience is more than & equal to 2 years 6 months then take round off
value as 3 years and if value is less than 2 year 6 months then take round off value as 2
years).

Note: If you have more than three Gynecologists, please add separate sheets and fill
accordingly.

29. Fill in the given box ‘1’ for Yes and ‘2’ for No.

30. Fill the number of Andrologists in the given boxes.

31. Please give the details of qualification of Andrologist:


• In column 2 of the table: Write the highest Qualification/degree in the space provided
and also fill the proper code in the given box. The codes are:- ‘1’ for Ph.D./DM/M.Ch., ‘2’
for MD/MS/DNB, ‘3’ for PG Diploma, ‘4’ for Any other. In case of “Any other”, please
specify in the given space.

• In column 3 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Urology, ‘2’ for General Surgery and ‘3’ for Any other. In case of “Any
other”, please specify in the given space.

• In column 4 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 5 of the table: Fill the experience in the area of Andrology (in yrs) in the
given boxes. In case, experience is in years and months then take round off value in
years(e.g. if the experience is more than & equal to 2 years 6 months then take round
off value as 3 years and if value is less than 2 year 6 months then take round off value
as 2 years).

Note: If you have more than three Andrologists, please add separate sheets and fill
accordingly.

32. Fill in the given box ‘1’ for Yes and ‘2’ for No.

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33. Fill the total number of Clinical Embryologists in given boxes.

34. Please give the details of qualification of Clinical Embryologist:


• In column 2 of the table: Write the highest Qualification/degree in the space provided
and also fill the proper code in the given box. The codes are:- ‘1’ for Ph.D./DM/M.Ch., ‘2’
for PG/MD/MS/DNB/M.V.Sc., ‘3’ for PG Diploma, ‘4’ for Diploma, ‘5’ for
MBBS/B.V.Sc./B.Sc. and ‘6’ for Any other. In case of “Any other”, please specify in the
given space.

• In column 3 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Medicine, ‘2’ for Life Sciences, ‘3’ for Veterinary Sciences and ‘4’ for
Any Other. In case of “Any other”, please specify in the given space.

• In column 4 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 5 of the table: Fill the experience in the area of Embryology (in yrs) in the
given boxes. In case if experience is in years and months then take round off value in
years(e.g. if the experience is more than & equal to 2 years 6 months then take round off
value as 3 years and if value is less than 2 year 6 months then take round off value as 2
years).

Note: If you have more than three Clinical Embryologists, please add separate sheet and
fill accordingly.

35. Fill in the given box ‘1’ for Yes and ‘2’ for No.

36. Fill the number of Counselors in given boxes.

37. Please give the details of qualification of Counselor:


• In column 2 of the table: Write the highest Qualification/degree in the space provided
and also fill the proper code in the given box. The codes are:- ‘1’ for Ph.D./DM/M.Ch., ‘2’
for PG/MD/MS/DNB, ‘3’ for PG Diploma, ‘4’ for Diploma, ‘5’ for Graduate/MBBS and ‘6’
for Any other. In case of “Any other”, please specify in the given space.

• In column 3 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Social Sciences, ‘2’ for Psychology, ‘3’ for Life Sciences, ‘4’ for
Medicine and ‘5’ for Any other. In case of “Any other”, please specify in the given space.

• In column 4 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 5 of the table: Fill the experience in the area of counseling in ART (in yrs) in
the given boxes. In case if experience is in years and months then take round off value
in years (e.g. if the experience is more than & equal to 2 years 6 months then take round
off value as 3 years and if value is less than 2 year 6 months then take round off value
as 2 years).

38. Please fill the total number of staff members employed in your ART Clinic other than the
staff specified above.

39. Please give the details of each staff:

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• In column 2 of the table: Write the name of the post in the space provided and please
do not fill the dotted boxes.

• In column 3 of the table: Write the highest Qualification/degree in the space provided
and also fill the proper code in the given box. The codes are:- ‘1’ for Doctorate, ‘2’ for
Post Graduate, ‘3’ for Graduate, ‘4’ for Diploma, ‘5’ for under Graduate and ‘6’ for Any
other. In case of “Any other”, please specify in the given space.

• In column 4 of the table: Write the Area/Discipline in the space provided and fill in the
given box ‘1’ for Medicine, ‘2’ for Nursing, ‘3’ for Life Sciences, ‘4’ for Social Sciences,
‘5’ for Psychology and ‘6’ for Any other. In case of “Any other”, please specify in the
given space.

• In column 5 of the table: Fill in the given box ‘1’ for Regular and ‘2’ for Part-Time.

• In column 6 of the table: Please file the total number of the persons employed for that
particular post.

Note: If you have more than 10 staff members then please add separate sheets and fill
accordingly.

SECTION - III (INFRASTRUCTURE)

40. Fill in the given box ‘1’ for Yes and ‘2’ for No.

41. From 41 (a) to (h): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

42. Fill in the given box ‘1’ for Yes and ‘2’ for No.

43. Fill in the given box ‘1’ for Yes and ‘2’ for No.

44. From 44 (a) to (k): Please fill in the given box ‘1’ for Yes, ‘2’ for No. In case of not
applicable then enter ‘9’ in the given box (Here not applicable means that your ART Clinic
does not have that particular procedure/facility).

45. From 45 (a) to (hh): Please fill in the given box ‘1’ for Yes and ‘2’ for No. In case of not
applicable then enter ‘9’ in the given box (Here not applicable means that your ART Clinic
does not has that particular procedure/facility).

46. Fill in the given box ‘1’ for Yes and ‘2’ for No. If No, then skip to Question no. 48, otherwise
continue.

47. From 47 (a) to (n): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

48. Fill in the given box ‘1’ for Yes and ‘2’ for No.

49. Fill in the given box ‘1’ for Single Laboratory and ‘2’ for Multiple Laboratories. If ART clinic
outsourcing from single Laboratory, then skip to Question No. 51, otherwise continue.

50. Fill the total number of multiple laboratories in the given boxes from where your ART Clinic
has got hormone assay facility.

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51. Please fill the name of the outsourcing Laboratory in the space provided and distance (in
kms) of the outsourcing Laboratories from your ART Clinic in the given boxes. Please do
not fill the dotted boxes.

52. Fill in the given box ‘1’ for Yes and ‘2’ for No.

53. Fill in the given box ‘1’ for Yes and ‘2’ for No. If Yes, then skip to Question no. 56, otherwise
continue.

54. Fill in the given box ‘1’ for Yes and ‘2’ for No.

55. Please fill the distance (in kms) of the Specialty Laboratory from your ART Clinic in the
given boxes.

56. Fill in the given box ‘1’ for Yes and ‘2’ for No.

57. Please specify the reason for microbiological laboratory not able to carry out rapid test for
infection in the space provided (Do not fill the dotted box).

58. Fill in the given box ‘1’ for Yes and ‘2’ for No. If Yes, then skip to Question no. 61, otherwise
continue.

59. Fill in the given box ‘1’ for Yes and ‘2’ for No.

60. Please fill the distance (in kms) of the Specialty Laboratory from your ART Clinic in the
given boxes.

61. Fill in the given box ‘1’ for Yes and ‘2’ for No. If Yes, then skip to Question no. 64, otherwise
continue.

62. Fill in the given box ‘1’ for Yes and ‘2’ for No.

63. Please fill the distance (in kms) of the Specialty Laboratory from your ART Clinic in the
given boxes.

64. From 64 (a) to (d): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

65. Fill in the given box ‘1’ for Yes and ‘2’ for No.

66. Please specify the reason for not maintaining the records in the space provided and do not
fill the dotted box.

67. From 67 (a) to (d): Please fill in the given box ‘1’ for Yes, ‘2’ for No.

68. Fill in the given box ‘1’ for Yes and ‘2’ for No.

69. Fill in the given box ‘1’ for Yes and ‘2’ for No.

70. Fill in the given box ‘1’ for Yes and ‘2’ for No. If No, then skip to Question No. 72.

71. Fill in the given box ‘1’ for Yes and ‘2’ for No.

72. From 72 (a) to (j): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

73. Fill in the given box ‘1’ for Yes and ‘2’ for No. If No, then skip to Question No. 75.

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74. From 74 (a) to (d): Please fill in the given box ‘1’ for Yes and ‘2’ for No and In case of
“Others” please specify the source in the space provided.

75. Please specify the reason for not having appropriate provision for power backup in the
space provided and do not fill the box.

SECTION - IV (PROCEDURES)
76. From 76 (a) to (w): Please fill in the given box ‘1’ for Yes and ‘2’ for No and in case of
others please specify the ART procedure in the space provided.

77. Fill in the given box ‘1’ for Yes and ‘2’ for No.

78. From 78 (a) to (f): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

79. (I) Work-up


• From (a) to (b): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

(II) Male Factors


• From (a) to (f): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

• For Question No. b (II): Please fill in the given box ‘1’ for Routine Test, ‘2’ for
Culture Test (antibiotic sensitivity test) and ‘3’ for Both.

(III) Female Factors


• From (a) to (p): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

• For Question No. d [I (v)]: Please specify the drug used for ovulation induction in
IUI in addition to above in the space provided and do not fill the dotted box.

• For Question No. d [II (vi)]: Please specify the drug used for ovulation induction in
IVF in addition to above in the space provided and do not fill the dotted box.

• For Question No. f (ii): Please fill in the given box ‘1’ for Routine Test, ‘2’ for
Culture Test (antibiotic sensitivity test) and ‘3’ for Both.

(IV) Andrology
A. Basic
• From (a) to (d): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

• For Question No. b: Please specify the method for semen analysis followed
other than WHO in space provided and do not fill the dotted box.

B. Advanced (sperm function test)


• From (a) to (c): Please fill in the given box ‘1’ for Yes and ‘2’ for No.

80. Category of ART Clinic will be filled by the ICMR (Please do not fill the dotted boxes).

81. From Question no. 81 (a) to (g) will be filled by the ICMR (please do not fill the
information in the space provided and in the dotted boxes).

Note: The Proforma should be duly signed by the Director or In-Charge of the ART Clinic
along with the official seal/stamp on each page of the proforma and also in the space
provided at the end.

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