The UK Womb Transplant Research Team is to expand its research with a series of transplants using the wombs of living donors.

The team already has permissions to begin a programme of 10 transplants using organs taken from brain dead donors. There will now be another five operations involving live donors and it is hoped that the programme will begin later this year.

Team leader, consultant gynaecologist Mr Richard Smith, said that new and much safer organ retrieval techniques, which have proved very successful in a programme in Dallas, Texas, mean that the time taken for the operation has been reduced dramatically.

“Patient safety has always been of paramount importance to our team and we have changed our protocols to include proven advances achieved by respected transplant teams elsewhere in the world,” he said.

“Risks for the live donor have been reduced considerably and we will be working with the team from Dallas who have recently announced that two babies have been born following the innovations they have introduced.”

“We hope to carry out the first operation of its kind in the UK later this year. However to complete both research programmes that will be running in parallel, we still need to raise more funds,” he said.

The announcement follows the publication by the Royal College of Obstetricians and Gynaecologists (RCOG) of a review of all uterine transplant research worldwide documented in its journal.

The Press Release announcing this review and the UK team’s announcement follows this announcement.

For more Media Information about the work of the UK Womb Transplant Team, please call Neil Huband on 07808 298989 or write to NHuband@PriorityCounsel.com

Press Release.

Under embargo 00:01 hours (UK time) Tuesday 5 June 2018

Womb transplants offer much hope, but remain an experimental procedure

Successful births following womb transplants are a major advance for women without a functioning uterus, but a group of doctors warn the procedure remains experimental and success of the practice still requires further strictly controlled clinical trials.

A team of doctors from Japan, writing in BJOG: An international Journal of Obstetrics and Gynaecology, explain that while recent developments in assisted reproductive technology have improved infertility treatment for many individuals, women without a functioning uterus have remained untreatable until recent developments in the pioneering field of womb transplantation.

In 2014, the first baby born to a woman with a womb transplant was delivered by doctors from the University of Gothenburg, Sweden. In 2017, a second team at Baylor University Medical Center, Texas, USA, delivered a baby born to a woman with a womb transplant. In total, 42 women worldwide have received transplanted wombs and 11 babies has been born up as a result until May 2017.

While womb transplants offer “great hope” for women, the practice is still considered to be experimental because its protocols have not been standardised, argue the team of doctors. They carried out review in order to discuss emerging concerns that need to be addressed.

Screening of donors and recipients depends on institutional protocol, such as good health and absence of infection and cancer, but more detailed criteria is needed, they argue.

This includes age of the donor and recipient and absence of other womb complications, and whether women with Mayer-Rokitankshy-Kuster-Hauser (MRKH) – where the vagina and womb to be underdeveloped or absent – should undergo vaginal reconstruction before receiving a transplant.

Many teams that perform womb transplants require an upper limit of 35-40 years for women who might undergo a transplant and an upper age limit of 55-65 years for donors, but the effect of age on the success of a transplant is currently unclear. The mean ages of the donors and recipients in the Swedish clinical trial were 51 and 30 years old, respectively.

Furthermore, other major complications for the recipient have included urinary tract complications, thrombosis, infection and haematoma.

Adverse side effects of immunosuppressants, which are used to reduce risk of rejection of a transplanted womb, may also play a role in the development of preeclampsia, and high-risk pregnancy monitoring is necessary, explain the authors.

Measures for the management of treatment-resistant rejection of the womb during pregnancy is still required and this remains a major task, they add. While all patients in the Swedish cohort achieved remission with steroid therapy, some developed rejection to the transplanted womb during pregnancy.

Surgical procedures for womb transplants, particularly for donor surgery, remain extremely invasive, and also need to be improved, potentially with the use of robot-assisted surgery, they add. To date, various surgical methods have been used including open, laparoscopic and robot assisted surgery. The authors argue robot assisted surgery could reduce major bleeding and time of the surgery and has shown potential by surgical teams in China and Sweden.

Dr Iori Kisu, lead author of the paper and Assisted Professor from the Department of Obstetrics and Gynecology at the Keio University School of Medicine, Japan, said:

“The first successful birth after a uterus transplantation attracted widespread international attention and many countries have since begun to prepare for the clinical use – so far with limited success. As our review of the available evidence shows, establishment of womb transplantation as a new and successful therapy will require strict clinical study data, and thorough training and testing in animal experiments, as well as international collaboration and information sharing.”

Mr J Richard Smith, spokesperson for the Royal College of Obstetricians and Gynaecologists and Clinical Lead at Womb Transplant UK, said:

“Infertility can have a devastating impact upon couples, particularly for women with absolute uterine factor infertility, for which there has been no effective treatment to date and – for some of these women, womb transplantation is the only way they can carry a pregnancy.

While there are a number of documented successful cases of women with womb transplants giving birth, we must be cautious and employ appropriate, selection and preparation processes to ensure the safety and efficacy of the therapy for women and their babies.

The procedure whereby living donors donate their wombs has become simpler reducing the time taken to retrieve a womb to less than 4 hours. This increases safety for live donors. As a result of this innovation, the UK Womb Transplant team now intends to follow both a live donor and a cadaveric donor programme in parallel.

All of the studies worldwide must collate data to maximise patient safety for both donors and recipients. This is particularly important where most of the living donors are either the mothers or sisters of the recipients, naturally involving strong emotions between donor and recipient which can make the consent process that more convoluted.“

Dr Patrick Chien, deputy editor of the journal BJOG, said:

“Womb transplantation is a promising area of fertility treatment that is beginning to advance worldwide. This is the first review to bring together published literature in order to synthesis and evaluate the existing concerns and unknowns of the procedure.”

ENDS

Note to editors

For media enquiries please contact the RCOG press office on +44 (0)20 7045 6773 or email pressoffice@rcog.org.uk

What is uterine factor infertility?

Thousands of women worldwide are affected by uterine factor infertility, a condition that describes infertility in women born without a uterus, loss the organ due to hysterectomy for cancer or postpartum haemorrhage, or a congenital defect, such as Mayer-Rokitankshy-Kuster-Hauser.

According to Womb Transplant UK, latest estimates show that 1 in 500 women of child bearing age suffer from absolute uterine factor infertility – approximately 50,000 women.

Women with uterine factor infertility are unable to carry a pregnancy – the only way to have a biologically related child is through surrogacy. However, surrogacy is prohibited in many countries, including Italy, Germany, Pakistan and Saudi Arabia. A womb transplant is the first and only treatment that enable these women to carry a pregnancy.

How does a womb transplant work?

IVF is carried out using the sperm and eggs of the recipient couple. The womb is removed from the donor and transplanted into the recipient. After the recipient has womb and ovarian functioning, the embryos are transplanted in her uterus – this is generally planned after follow up of at least 1 year after the transplant. Pregnancy and delivery follows. The uterus is removed and immunosuppressants are stopped after birth. [Refer to image on page 2].

Embargo link: https://www.dropbox.com/s/rjygvsvzc8cvolv/Final%20manuscript.PDF?dl=0

Public link to paper: https://doi.org/10.1111/1471-0528.15230.000:1–5

Please cite this article as: Please cite this paper as: Kisu I, Kato Y, Obara H, Matsubara K , Matoba Y, Banno K, Aoki D. Emerging problems in uterus transplantation.

About BJOG

BJOG: An International Journal of Obstetrics and Gynaecology is owned by the Royal College of Obstetricians and Gynaecologists (RCOG) but is editorially independent and published monthly by Wiley. The journal features original, peer-reviewed, high-quality medical research in all areas of obstetrics and gynaecology worldwide. Please quote ‘BJOG’ or ‘BJOG: An International Journal of Obstetrics and Gynaecology’ when referring to the journal. To keep up to date with our latest papers, follow @BJOGTweets.

About the RCOG

The Royal College of Obstetricians and Gynaecologists is a medical charity that champions the provision of high quality women’s healthcare in the UK and beyond. It is dedicated to encouraging the study and advancing the science and practice of obstetrics and gynaecology. It does this through postgraduate medical education and training and the publication of clinical guidelines and reports on aspects of the specialty and service provision.