Uterine transplantation bjog

Uterine Transplantation
Scientific Impact Paper No. 65
April 2021
Please cite this paper as: Jones BP, Saso S, Yazbek J, Thum M-Y, Quiroga I, Ghaem-Maghami S, Smith JR, on behalf of the
Royal College of Obstetricians and Gynaecologists. Uterine Transplantation. Scientific Impact Paper No. 65. BJOG.
2021;128:e51–e66.

DOI: 10.1111/1471-0528.16697 RCOG Scientific Impact Paper
Uterine Transplantation
BP Jones, S Saso, J Yazbek, M-Y Thum, I Quiroga, S Ghaem-Maghami, JR Smith, on behalf of the
Royal College of Obstetricians and Gynaecologists
Correspondence: Royal College of Obstetricians and Gynaecologists, 10–18 Union Street, London SE1 1SZ, UK.
Email: clinicaleffectiveness@rcog.org.uk
Plain language summary
A uterine transplant, or womb transplant, provides a potential treatment for women who cannot become
pregnant or carry a pregnancy because they do not have a womb, or have a womb that is unable to maintain a
pregnancy. This is estimated to affect one in 500 women. Options for those who wish to start a family include
adoption and surrogacy, but these are associated with legal, cultural, ethical and religious implications that may
not be appropriate for some women and their families. A womb transplant is undertaken when the woman is
ready to start a family, and is removed following the completion of their family.
Womb transplants have been performed all over the world, with more than 70 procedures carried out so far. At
least 23 babies have been born as a result, demonstrating that womb transplants can work. While the procedure
offers a different option to adoption and surrogacy, it is associated with significant risks, including multiple major
surgeries and the need to take medications that help to dampen the immune system to prevent rejection of the
womb. To date there has been a 30% risk of a transplant being unsuccessful.
Although the number of transplants to date is still relatively small, the number being performed globally is growing,
providing an opportunity to learn from the experience gained so far. This paper looks at the issues that have been
encountered, which may arise at each step of the process, and proposes a framework for the future. However, long
term follow-up of cases will be essential to draw reliable conclusions about any overall benefits of this procedure.
1. Background
Uterine transplantation (UTx) is a potential therapeutic intervention for women with absolute uterine factor
infertility (AUFI). AUFI is widely considered to affect 1 in 500 women of childbearing age, and has been estimated to
impact 200 000 in Europe, 85 000 in the USA and up to 1.5 million women worldwide.1,2
AUFI refers to women
with infertility secondary to the absence of a uterus or the presence of one that is anatomically or physiologically
dysfunctional. The established routes to motherhood for women with AUFI include adoption or surrogacy, which to
many are suitable options. However, not only are these options associated with complex legal, financial, cultural,
ethical and religious factors, but they do not allow the experience of pregnancy. UTx provides an opportunity to
overcome some of these issues while giving women with AUFI the opportunity to conceive using assisted
reproductive technologies and experience pregnancy themselves.
RCOG Scientiﬁc Impact Paper No. 65 e52 of e66 ª 2021 Royal College of Obstetricians and Gynaecologists

At the time of publication of this paper, more than 70 procedures have been performed and 23 live births have been
published, or reported in the media.3–5
Following the development of the International Society of Uterine
Transplantation and the establishment of teams performing the procedure globally, it is anticipated that UTx will
transition from research concept to clinical care in the future.
The purpose of this Scientific Impact Paper is to summarise the pertinent published literature on UTx and to
propose a framework for establishing a sustainable UTx programme in the UK. The data presented herein refer to
the 45 cases,5
and the 17 live births published in peer reviewed journals to date. This includes cases that have been
performed in Saudi Arabia, Turkey, Sweden, Xian (China), Czech Republic, Cleveland (USA), Dallas (USA), Brazil,
Germany and India.
2. Alternatives to uterine transplantation
Reproductive planning involves numerous factors that derive from each individual’s/partner’s values, which may be
influenced by social or cultural norms, and the resources available to them. Women with AUFI have traditionally
remained childless or considered the option of adoption or surrogacy.
There are pros and cons to adoption and surrogacy and it is, therefore, important for women with AUFI to ensure
they are well-informed about their options. For adoption, in the UK, women can gain information through
government websites, and for surrogacy the HFEA (Human Fertility and Embryology Authority) has signposted
sources to obtain information (Surrogacy UK, Brilliant Beginnings, Childlessness overcome through surrogacy
[COTS]). Moreover, specialist fertility counsellors are available to help women considering surrogacy and adoption
through the NHS, or privately using accredited therapists accessed through organisations such as the British
Infertility Counselling Association (BICA).
While adoption and surrogacy provide options for women with AUFI who wish to become mothers, they do not
restore the anatomical issue underlying the cause of their infertility. Women born with AUFI will therefore never
experience menstruation, which to some women is part of being female and has been shown in a small study
involving 12 participants to contribute to a female gender identity.6
Furthermore, adoption and surrogacy do not give
the experience of pregnancy, which has been demonstrated to be the primary motivator in 63% of women with
AUFI who request UTx.7
While UTx is associated with greater physical risk, including multiple major surgeries and
the necessity to take immunosuppression while the donor transplant is in situ, it does allow the recipients to
experience pregnancy, and overcomes some of the legal and religious issues associated with surrogacy. Although
there is no direct alternative to UTx, it is essential that consideration is given to adoption and surrogacy in the
counselling process for UTx. This ensures the consent process is fully informed, and the additional risks associated
with UTx can be appropriately considered in the context of the perceived individualised benefits.
3. Potential recipients
Potential recipients to undergo UTx are women of reproductive age with AUFI, the causes of which may be congenital
or acquired, as summarised in Appendix I. Out of the 45 reported cases, 40 (89%) were performed in women with
Mayer–Rokitansky–K€
uster–Hauser (MRKH) syndrome. Four (9%) cases were undertaken following hysterectomy (one
for postpartum haemorrhage,8
one after cervical cancer,9
two following failed myomectomy5
). One (2%) case was
undertaken in a woman with Asherman syndrome who underwent preparatory hysterectomy at the time of UTx.10

3.1 Mayer–Rokitansky–K€
uster–Hauser syndrome
MRKH has an incidence of 1 in 5000 women.11
It arises due to incomplete development of the M€
ullerian ducts. MRKH
manifests with congenital absence of the uterus, although rudimentary small uterine bulbs and fallopian tubes may
remain, along with variable degrees of vaginal shortening. Therapeutic intervention is often required to optimise vaginal
diameter and depth to enable sexual function. Various methods exist including dilator therapy, the Vecchietti
procedure or the formation of a surgically-created vagina, referred to as a neovagina, using skin, peritoneum, amnion
or intestine.12,13
The novel use of autologous in vitro cultured vaginal tissue has also been demonstrated with
promising results.14
Generally, women with MRKH have normally functioning ovaries, making them suitable candidates
for UTx. A study assessing perceptions to UTx among women with MRKH showed that almost two-thirds of
participants were willing to undergo the procedure, with a full understanding of the potential risks involved.15
For women being considered for UTx, there are specific preoperative requirements. A physiologically functioning
and normal length vagina (measuring 7 cm or more) is considered a requisite for some teams, which excludes
women who have a neovagina. The surface of the vagina is composed of stratified squamous epithelium, which as a
protective mechanism desquamates into the vaginal lumen, concomitantly removing adherent micro-organisms.16
Vaginal epithelium also contributes to the innate immune response by facilitating the recognition of pathogens and
stimulating the production of antimicrobial peptides and proinflammatory cytokines.17
These immunomodulatory
mechanisms contribute to the maintenance of a commensal microbiome, which have clinical and reproductive
implications that may impact outcomes in UTx.18
For example, the second global UTx case was performed in a
woman with an intestinal neovagina,19
where despite numerous failed in vitro fertilisation attempts and multiple
miscarriages, a live birth has yet to occur.20
Women with atypical MRKH, specifically those with renal abnormalities, may also be considered for UTx. Caution
should be taken in those with unilateral renal agenesis, which affects around a quarter of cases,21
owing to the more
than two-fold increased risk of hypertensive disorders in pregnancy including pre-eclampsia.22
In a Swedish cohort
who underwent UTx, three had unilateral kidney agenesis, and all three developed a hypertensive disorder during
pregnancy that necessitated intervention for early birth.23
Those with pelvic kidneys require additional assessment
utilising magnetic resonance imaging or computerised tomography scanning, to localise the pelvic kidney and
determine if it would be an impediment to subsequent UTx.
3.2 Hysterectomy
Reasons for hysterectomy in women of reproductive age include benign gynaecological disease, gynaecological cancer
(such as cervical cancer) or severe postpartum haemorrhage. Caution is required in women having UTx following
previous cancer diagnoses, because of the potential risk of recurrence as a consequence of the necessity for
immunosuppression postoperatively. In kidney transplantation, a history of previous cancer is associated with a 30%
increased risk of death in the recipient.24
Moreover, across all solid organ transplants, a meta-analysis found that
all-cause mortality, cancer-specific mortality and the risk of developing a new primary malignancy was greater in
those with a pre-transplant diagnosis of cancer compared with recipients with no pre-transplant malignancy.25
As
such, additional counselling is required in these women, and it is prudent to allow a period of at least 5 years in
remission before they are considered for UTx. While no meaningful conclusion can be taken from a single case, the
one UTx case performed in a woman with a previous diagnosis of cancer, which in this case was of the cervix, gave
birth to two live babies,23
and following completion hysterectomy, there have been no reports of recurrence or new
diagnoses of cancer.

3.3 Asherman syndrome
Asherman syndrome, where the uterus is present with dysfunctional endometrium, affects up to 1.5% of women of
reproductive age.26
Characterised by the formation of adhesions inside the uterus and/or the cervix, this condition
can cause amenorrhea, recurrent miscarriage and infertility. Fertility restoration can be achieved using hysteroscopic
adhesiolysis, although high rates of infertility, miscarriage, poor implantation and abnormal placentation remain.27
Performing UTx for Asherman syndrome should only be considered for severe cases, where all other treatment
options have been exhausted.
3.4 Male-to-female transgender women
Under the Equality Act (2010), individuals who are proposing to undergo, currently undergoing, or have undergone a
process of gender reassignment cannot be subjected to discrimination based on this characteristic alone.
Subsequently, if UTx becomes a treatment option for all women (encompassing both cis-women and trans women)
with AUFI, based on EU and UK legislation it will, in the absence of the provision of compelling justification, be
unlawful not to perform UTx in trans (or transgender) women. Despite a number of anatomical, psychosocial,
physiological, fertility and obstetric considerations that require further research before UTx can be performed in
transgender women, there is no overwhelming clinical argument against performing this procedure.28
3.5 Other causes
Other less common causes of AUFI include severe or complex congenital uterine anomalies, radiotherapy damage
and complete androgen insensitivity syndrome. Owing to the complex nature of these conditions, the role of UTx in
these cases is at present unclear.
4. Potential donors
Living donors have been used in 80% of UTx cases performed so far (n = 36),5,9,10,29–34
while the remaining cases
used deceased donors (n = 9; 20%).5,19,34–36
In cases where the parity of the donor was known (n = 43), the
majority have been multiparous (n = 40; 93%) while three were nulliparous (7%).19,34
4.1 Living donors
Logistically, given the diverse array of multidisciplinary expertise required, planning an elective surgery using living
donors is more straightforward than the on-call arrangement needed in the context of deceased donation. The
routine investigations undertaken for other solid organ transplant apply equally to UTx donors, including
microbiological screening to prevent transmitted infection such as HIV, hepatitis B and C, cytomegalovirus, Epstein-
Barr virus, syphilis, toxoplasma, and human T-cell lymphotropic virus. The use of living donors allows greater time
for further investigations which are specific to UTx, which at a minimum should include a cervical smear/human
papillomavirus testing, tests to exclude sexually transmitted infections (chlamydia, gonorrhoea and trichomoniasis)
and a vaginal culture to exclude Candida species and bacterial vaginosis. A transvaginal ultrasound scan should also be
undertaken to exclude structural abnormalities, and magnetic resonance angiography or computed tomography
angiography to provide information about vessel morphology, calibre and patency.

Just over half of the 36 living donor cases undertaken so far have been related to the recipients (n = 19; 53%), the
majority being a maternal relation (n = 16), where one sister and two aunts also donated. The remainder (n = 17)
were unrelated. While the use of first-degree relatives may provide immunological benefit,37
the use of older donors
is associated with other risk factors. Significantly, increasing age correlates with risk of atherosclerotic change in the
pelvic arteries, which may result in an organ of insufficient quality for implantation.29
Moreover, even before
macroscopic or histological evidence of atherosclerosis is evident, increasing age has been shown to cause arterial
inflammation,38
which may increase the likelihood of post-transplant graft vasculopathy.39
In addition, increasing
donor age, irrespective of recipient age, increases the rate of acute allograft rejection in other solid organ
transplants.40
The feasibility of the procedure using this donor type is difficult to refute as there have been 20 live births using
living donors. However, the major disadvantage in living donors is the significant risk to the donor.
Regarding donor surgical morbidity in the cases performed so far, four (11.4%) donors suffered complications
requiring further surgical intervention. Two of whom sustained intraoperative ureteric lacerations that were repaired
immediately;30,34
while one donor re-presented with a uretovaginal fistula that required initial pyelostomy and
subsequent ureteric implantation 5 months after surgery – this was attributed to diathermy related partial ureteric
injury during a difficult retrieval.9
While the reported rate of ureteric injury in benign gynaecological surgery is less
than 1%, it is more than 10% of uterine cancer cases.41
The injury rate is higher in oncological cases owing to
pathology-related complexity, whereas UTx donor retrievals are not associated with such issues by virtue of the
selection criteria. However, the need to preserve the uterine veins in view of their unpredictable and tortuous
course and particularly close proximity to the ureter, presents increased surgical risk in UTx retrievals. Evolution of
the surgical technique,42
utilising the ovarian or utero-ovarian veins instead of the uterine veins,31,32
should reduce
surgical risk in future cases. The other reported complication requiring surgical intervention under general
anaesthesia was a vaginal cuff dehiscence.31
Ten donors experienced deviation from the normal postoperative course
or complications requiring pharmacological treatment. These included urinary tract infections,5,38
faecal impaction,31
wound infection,9
bladder hypotonia,34
leg/buttock pain,31
anaemia,5
respiratory failure during anaesthesia5
and
depression.31
Extensive multidisciplinary counselling is therefore essential, with thorough explanation of the potential
risks, to ensure that all donors can give informed consent, in the absence of undue pressure or coercion.
4.2 Deceased donors
The use of deceased donors ultimately negates donor risk, and allows a more radical dissection, which enables larger
calibre vessels to be taken, theoretically reducing the risk of graft thrombosis. This conclusion was reached following
animal research, where smaller vessel anastomoses, such as the uterine vessels, resulted in gradual vessel
thrombosis.43
Subsequent studies utilising larger vessel patch techniques substantiated the concept, following
successful UTx and pregnancies in both small and large animal models.44–46
In human cases, the uterine graft has successfully been retrieved as part of a multiorgan retrieval with no adverse
impact upon other organs retrieved. The uterus has been retrieved before the lifesaving organs in some cases,47,48
and after in others.49–51
Appropriate preoperative investigation of the donor can still be undertaken, with
transvaginal ultrasound scan, a sexually transmitted infection screen and cervical cytology/human papillomavirus
testing being expedited to ensure results are available within the pre-retrieval period. In this time the donor can
be physiologically optimised while other retrieval teams perform their preliminary investigations. Donor
optimisation sees a shift in management strategy from one directed towards resuscitation of the cerebral injury, to

one that focuses on restoration of physiological and metabolic homeostasis to prevent organ deterioration.
Donation of the uterus in the UK is currently dependent upon the donor having consented, and therefore donor
family consent would be required. Initial studies in the USA indicated a poor potential uptake from donor families,
with as few as 6% of families agreeing to procurement of the uterus.49
However, a more recent French study
found that donation of the uterus was readily accepted, with no refusals (n = 14) and no negative impact on the
donation of other organs.51
A potential drawback to using deceased donors is the associated systemic brain-death inflammation that may
influence organ quality.52
Moreover, by virtue of the logistical challenges of retrieving from deceased donors, which
may be undertaken in a different hospital to the implantation, the cold ischaemic time in cases so far has been
5 hours 42 minutes, compared to 2 hours 50 minutes in living donor cases.5
This increases the potential for
ischaemia–reperfusion injury, which may increase risk of acute and chronic rejection, as well as chronic graft
dysfunction.53,54
However, in both animal and human models UTx grafts tolerated cold ischaemic times of up to
24 hours,51,55,56
so the prolonged cold ischaemic time seen in deceased donation is of uncertain significance. The risk
of fungal infection may also be greater, owing to potential contamination of the sterile vessels from organisms within
the non-sterile vaginal cuff, as exemplified by the unsuccessful first UTx carried out in the USA taken from a
deceased donor after brain death, which resulted in hysterectomy following haemorrhage due to candida-associated
vasculitis within the uterine vessels.36
The first successful live birth following UTx using a deceased donor occurred in Brazil in 2017, demonstrating the
feasibility of using this donor type.35
However, further long-term follow-up and more cases are required before
accurate comparison of efficacy between donor types can be undertaken.
5. Surgical considerations
UTx entails transplantation of the uterus, including the cervix, a cuff of vagina, the surrounding ligamentous and
connective tissues, as well as the major blood vessels supplying and draining the uterus. Donor surgeries have been
predominantly performed using a midline laparotomy approach (n = 39), while minimally invasive surgical techniques
have been proposed,57
and recently implemented in six cases – four of which were laparoscopic-assisted, while one
utilised a robotic approach.10,33,39
While unpublished, several further cases have been performed which illustrate that
the transition towards the use of minimally invasive retrieval techniques is already in progress.
With regards to graft survival, just over a quarter (n = 13) of recipients subsequently underwent emergency
hysterectomy. The most common indication was graft thrombosis, which was present in around half of the cases
(n = 7).9,30,31,34
Three were prompted by infective causes: one due to a pelvic bacterial infection/abscess which failed
to respond to conservative measures;9
another because of candida-associated vasculitis of the arterial anastomosis;36
and another case failed because of herpes simplex infection of the graft.34
Two cases were reported to have been
unsuccessful secondary to graft ischaemia of unspecific aetiology.31
A final case was complicated by postoperative
haemorrhage which led to resultant graft failure.5
Postoperatively, three-quarters (n = 7) of emergency
hysterectomies occurred during the first 15 postoperative days.
With regard to donor type, graft survival among cases so far using living donors has been 75% (27/36), whereas in
deceased donors it has been 56% (5/9). Seven women have had completion hysterectomies after successful
pregnancies. The remainder continue to have functioning grafts. All successful UTx procedures have resulted in

menstruation without the need for supplementary hormone therapy; this can be taken as a reliable indicator of
uterine functionality and ongoing wellbeing.
In addition to the graft failures, surgical complications in UTx recipients have included five complications necessitating
further surgical intervention including a vesicovaginal fistula (n = 1) and vaginal stenosis of the uterine-vaginal
anastomosis requiring dilation and stenting (n = 4).34
Five recipients experienced deviation from the expected
postoperative course or complications requiring pharmacological treatment, such as pleural effusions (n = 2)9
and
urinary tract infections (n = 3).34,58
6. Immunological considerations
Rejection can be defined as destruction of the donor graft by the host’s immune response, activated against the
graft’s alloantigens because of a difference in donor-recipient genes. In UTx, the immune response of the recipient
towards the implanted graft can be just as deleterious as the host response in other transplanted organs. For all
solid organ transplants, it is essential the burden of immunosuppressive medications is offset by an improvement in
quality of life. As such, the minimum number of immunosuppressive agents should be used at the smallest dose
possible, while avoiding the use of steroids where possible. In UTx cases performed so far, tacrolimus has
predominantly been the preferred agent, initially in combination with mycophenolate mofetil (MMF), with or
without the addition of prednisolone. MMF is later withdrawn in anticipation of embryo transfer, owing to its
teratogenic nature,59
where it is usually replaced with azathioprine. An alternative regimen, using maintenance
tacrolimus and azathioprine immediately has been utilised more recently, with no difference in rejection
episodes.60
While symptoms of rejection include abdominal pain, fever or vaginal discharge/bleeding, such symptoms would only
become apparent once rejection had been firmly established. A preliminary grading system for uterine allograft
rejection was proposed following a study on baboons, which concluded that cervical biopsies were a consistent,
achievable means of detecting rejection in the graft.61
In the available data from human cases to date there have been
26 episodes of rejection in 17 recipients. The majority of episodes were proven on histology (n = 24), using cervical
biopsies,9,62
while two were diagnosed following the presentation of symptoms suggestive of rejection in terms of
raised serum lymphocyte subpopulations.34,39
The majority of the histologically proven cases of rejection (n = 21;
88%) were mild or moderate, while three (12%) were severe.57
The majority of episodes of rejection were
successfully managed with a 3-day course of intravenous methylprednisolone, although severe episodes required the
addition of antithymocyte globulin.
A unique advantage of UTx over other solid organ transplants is that it is temporary, and once the woman’s family is
complete, the graft can be removed, allowing the cessation of immunosuppression. Given that immunosuppression-
associated morbidity, such as in cancer, diabetes and nephrotoxicity, is dose and duration dependant,63
the
anticipated implications in UTx are expected to be less than in lifelong organ transplants, although long term data
following UTx are required.
7. Fertility considerations
While the fallopian tubes are usually retrieved during UTx as part of the graft in order to facilitate uterine
manipulation, they are subsequently removed post implantation to reduce the future risk of ectopic pregnancy. As

such, prior to UTx, the creation and cryopreservation of embryos is required. Not only does this guarantee the
availability of embryos postoperatively but reduces the overall risk compared with performing egg collections after
UTx, when anatomy may be distorted and there is increased risk of infection following the introduction of
immunosuppression. Following the development of vitrification techniques, the success rates of using vitrified
embryos are now similar to those with fresh embryos,64
which minimises any potential negative impact of
cryopreservation on embryo quality.
Multiple gestation would be particularly problematic following UTx, where the added risks for complications, such as
preterm labour, miscarriage, pre-eclampsia and gestational diabetes, greatly potentiates antenatal risk. Consequently,
single embryo transfer should always be implemented following UTx. Embryo transfer was initially delayed until at
least 12 months postoperatively,65
as per standard solid organ transplant guidance.66
However, in more recent
cases,38
a period of 6 months has been adopted, which allows sufficient time for surgical healing and stabilisation of
the immunosuppression regime. In anticipation for embryo transfer, it is essential to review medications that may be
unsafe for pregnancy.
Tacrolimus and azathioprine have consistently been shown as safe to administer during pregnancy, with no increased
risk of congenital abnormality.67
However, potentially teratogenic immunosuppression, such as MMF, should be
stopped a minimum of 6 weeks prior to embryo transfer, and replaced by a different agent, such as azathioprine. In
cases where MMF has not been used, the potential time between implantation and embryo transfer can be reduced
further to 3 months, potentially reducing further cumulative immunosuppression exposure.60
8. Obstetric considerations
Twenty-three live births have now been reported following UTx; 20 from living donor and three from deceased
donor operations.4
Outcomes have been published from 17 of these cases.68
Antenatal complications experienced in the published cases so far include pre-eclampsia (n = 3), obstetric
cholestasis (n = 2) and preterm prelabour rupture of membranes (n = 1). The women who developed pre-
eclampsia all gave birth preterm between 31 and 35 weeks of gestation, but babies were an appropriate weight
for their gestational age.23
While in vitro fertilisation,69
or the transplant of postmenopausal uteri, with an
inherently less elastic vasculature could contribute to the development of hypertensive disorders of pregnancy,70
it
should be noted that all of the women who developed pre-eclampsia had a single kidney.23
The risk–benefit ratio
in women with this condition is clearly increased which has led to their exclusion from certain research studies,71
but inclusion in others.34
Other complications have included a subchorionic haematoma that resolved
spontaneously,72
and an episode of pyelonephritis that required inpatient management with intravenous
antibiotics.35
To date all offspring have been delivered by lower section caesarean section. This is primarily owing to uncertainty
regarding structural support and vascular supply to the graft during labour. Four cases underwent concomitant
peripartum hysterectomy.68
All infants were born in good condition with no reports of congenital abnormality.
Regarding the potential impact of tacrolimus on the fetus, there is a small theoretical risk of reversible neonatal
hyperkalaemia and renal impairment, which requires consideration postnatally. However, while tacrolimus is excreted
in breast milk, infant ingestion is less than 1% of the maternal dosage,73
and breastfeeding has not been shown to
contribute to infant tacrolimus concentrations after birth, so is considered safe.74

9. Psychological considerations
Not only does AUFI result in an inability to conceive, but can also result in significant psychological sequelae. More
than a third of infertile women develop severe symptoms of depression and have been shown to have a two-fold
increased risk of suicide.75
The inability to bear children may also affect personal perceptions of femininity and
impact negatively on the quality of life.76
Owing to the interrelationship between infertility and psychological
wellbeing, specialist psychological evaluation, counselling and follow-up is required in UTx for the recipients and,
where applicable, the donors.
The psychological aspects of UTx for recipients77,78
and donors79
have been examined, such as psychological
wellbeing, relationships, managing childlessness, relationship with the donor, and knowledge about associated risks.
Participants, as well as their partners, did not report any psychological issues at baseline, nor following the
procedure, despite adverse events, such as episodes of rejection, which were confirmed quantitively using SF-36 and
Fertility Quality of Life (FertiQoL), the Hospital Anxiety and Depression Scale (HADS) and Dyadic Adjustment Scale
(DAS) questionnaires. Many recipients expressed relief by the onset of menstruation following UTx, as it not only
demonstrated graft function but made them feel like other woman with menstrual cycles. There was no significant
impact post UTx on sexual desire or satisfaction.
Regarding psychological outcomes in donors, semi-structured interviews in combination with questionnaires including
the Psychological General Well-Being (PDWB) Index, DAS, HADS and SF-36 were used in the selection process.
Two donors experienced a deviation from their baseline quality-of-life scores (SF-36). One such case coincided
chronologically with the donor suffering complication with a uretovaginal fistula in addition to the graft loss in the
recipient, who was her daughter. Overall, there was no significant change in quality of life across donors between
baseline and 12 months, and over the same timeframe there was a reduction in HADS score. None of the donors
reported feelings of regret, even in those who had experienced a complication or whose recipients suffered graft
loss. All donors resumed their preoperative social and physical activities. These findings resonate with the positive
psychosocial outcomes demonstrated following lifesaving solid organ donation.80,81
10. Ethical considerations
UTx incorporates complex bioethical issues that govern both assisted reproduction technologies and the field of
organ transplantation. The overriding goal in UTx is to provide net benefit with minimalisation of harm, considering
donors, recipients, partners and future offspring. Only extensively counselled, fully informed women can decide
whether the potential benefit of UTx outweighs the significant risks associated with the process. While each case
should be individualised, it is likely the risks of UTx in women with significant medical comorbidities may outweigh
the potential benefits.
The option to use living or deceased donors raises particular bioethical issues. Following the passing of the Organ
Donation (Deemed Consent) Act 2019, the legalities in England surrounding deceased organ donation changed to an
‘opt out’ system. This presumes adult consent to organ donation by default, unless a decision to opt out has
previously been recorded. However, as is the case with other novel transplants, uterus donation is not included as
part of the opt-out strategy, meaning explicit consent is required from the donor’s family. While appropriate,
difficulties obtaining valid consent remain, owing to the novelty of the procedure and the necessity for use of proxy
consent through the donor’s family.82–84
Moreover, the possibility of UTx negatively impacting consent rates for

other organs, or the uterine retrieval causing an adverse impact on the multiorgan retrieval process require
consideration. Conversely, in living donation, the overriding issue is on the aforementioned significant donor risk. As
such it has been suggested that deceased donation should be prioritised, provided there is sufficient availability of
donor uteri, similar success rates and no demonstrable adverse impact on the multiorgan retrieval process.83,85
Although it is well-established that outcomes in other solid organ transplants are superior using living donation,
more cases and longer follow-up are essential before accurate comparisons can be made between the use of living
and deceased donation in the context of UTx.86
Moreover, it has been predicted that the deceased donor pool in
the UK may be less than 150 annually, prior to the implementation of selection criteria such as parity, medical and
surgical history, and reproductive and obstetric outcomes, which would reduce this pool significantly further.87
It is
likely that a combination of living and deceased donation will be necessary in the short-term future. If living donors
are used, minimising donor risk is essential, this can be achieved by utilising minimal access retrieval techniques
where possible and continuing to refine surgical techniques in order to reduce operative time and surgical risk.
The long-term future of UTx will undoubtedly focus on the development of a bioengineered uterine graft, which
would alleviate potential donor shortages and negate surgical risk to the donor and immunosuppression-related risk
in the recipient. While the concept remains in its infancy, the Swedish team have established a technique to repair a
rat uterus using a bioengineered uterine patch and have demonstrated functionality by achieving subsequent
pregnancies.88
This development has set the benchmark for the future of UTx, and with ongoing innovation and
collaboration, the options for fertility restoration in women with AUFI should continue to become more available
and acceptable.
11. Opinion
Although still under investigation, with only 23 live births worldwide, UTx offers the possibility of an alternative
option for women with AUFI to become mothers.
UTx is associated with significant morbidity, including three/four major surgeries (UTx, caesarean section/s and
hysterectomy to remove the transplant) and the risks associated with transient immunosuppression. Moreover,
in the cases performed so far almost 30% of grafts have been removed because of complications. Consequently,
recipients must be highly motivated, with excellent support networks, and have access to appropriate
psychological services and be fully informed of the potential risks involved.
More than 40 procedures using living donors have now been performed, resulting in at least 20 live births so
far, with transition into clinical practice expected in the future. The use of living donors necessitates
consideration of the significant potential risk to the donor, and priority must be given to putting in measures to
minimise such risks. As with recipients, counselling and support for donors are essential, including access to
psychological services if required.
Despite three successful live births being achieved through the use of deceased donors, this possibility continues
to remain a research concept with further cases needed, including extensive follow-up, before comparisons
between the efficacy of each donor type can be evaluated.
Owing to the procedure’s novelty, it is important to note that long term outcomes following UTx are not yet
available. As such, all cases should be registered with the international registry including follow-up of donors,
recipients and offspring.
At a time when UTx begins to transition into clinical practice, as is the case with all novel therapies and
interventions, it is essential there is robust governance in place to enable performance and safety monitoring.

Disclosure of interests
BPJ, SS, JY, MYT, IQ and SGM have declared no conflicts of interest. Full disclosure of interests for JRS, Scientific
Advisory Committee and peer reviewers are available to view online as supporting information.
Funding
All those involved in the development of Scientific Impact Papers, including the Scientific Advisory Committee,
Scientific Advisory Committee chair, developers, peer reviewers and other reviewers, are unpaid volunteers and
receive no direct funding for their work in producing the paper. The only exception to this are the Scientific
Advisory Committee members who receive reimbursement for expenses for attending Scientific Advisory
Committee meetings for standard RCOG activities; this is standard as per RCOG rules.
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Appendix I: Causes of absolute uterine factor infertility (AUFI)
Uterus present Asherman syndrome
Fibroids
Severe adenomyosis
Uterine malformation
Pelvic irradiation
Uterus absent Hysterectomy
– Obstetric haemorrhage
– Benign cause
– Cancer
Congenital
– Mayer-Rokitansky-K€
uster-Hauser (MRKH) syndrome
– Complete androgen insensitivity syndrome (CAIS)
– Male-to-female transgender

This Scientific Impact Paper was produced on behalf of the Royal College of Obstetricians and Gynaecologists by:
Mr BP Jones MRCOG, London; Mr S Saso MRCOG, London; Mr JM Yazbek MRCOG, London;
Dr M-Y Thum MRCOG, London; Miss I Quiroga FRCS, The Oxford Transplant Centre, Oxford University
Hospitals NHS Trust; Dr S Ghaem-Maghami MRCOG, London; and Mr JR Smith FRCOG, London.
The following individuals and organisations submitted comments during peer review:
Professor A Balen MD DSc FRCOG, Leeds; Professor M Br€
annstr€
om, University of Gothenburg, Sweden;
British Fertility Society; Dr R Chmel, Charles University and Motol University Hospital, Prague, Czech Republic;
Mr DI Fraser FRCOG, Norwich; Professor PK Heinonen, University of Tampere, Finland; Dr LS Michala FRCOG, Athens,
Greece; RCOG Women’s Network; Dr LLL Robinson FRCOG, Birmingham; and Dr G Testa MD, FACS, MBA,
Baylor University Medical Center at Dallas, Texas, USA.
The Scientific Advisory Committee lead reviewer was: Dr N Potdar FRCOG, Leicester.
The chair of the Scientific Advisory Committee was: Professor MD Kilby FRCOG, Birmingham.
All RCOG guidance developers are asked to declare any conflicts of interest. A statement summarising
any conflicts of interest for this Scientific Impact Paper is available from: https://www.rcog.org.uk/en/
guidelines-research-services/guidelines/sip65/.
The final version is the responsibility of the Scientific Advisory Committee of the RCOG.
The paper will be considered for update 3 years after publication, with an
intermediate assessment of the need to update 2 years after publication.
DISCLAIMER
The Royal College of Obstetricians and Gynaecologists produces guidelines as an educational aid to good clinical practice.
They present recognised methods and techniques of clinical practice, based on published evidence, for consideration by
obstetricians and gynaecologists and other relevant health professionals. The ultimate judgement regarding a particular
clinical procedure or treatment plan must be made by the doctor or other attendant in the light of clinical data presented
by the patient and the diagnostic and treatment options available.
This means that RCOG Guidelines are unlike protocols or guidelines issued by employers, as they are not intended to be
prescriptive directions defining a single course of management. Departure from the local prescriptive protocols or
guidelines should be fully documented in the patient’s case notes at the time the relevant decision is taken.

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