Uterine Transplantation in the Human Setting
Research type
Research Study
Full title
Can uterine transplantation in a human setting bring about a healthy pregnancy and subsequent birth of a live neonate?
IRAS ID
151536
Contact name
J. Richard Smith
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
5 years, 5 months, 31 days
Research summary
Women with absolute womb-related infertility are considered as being ‘unconditionally infertile’. Main causes are: congenital, mainly Mayer-Rokitansky-Kuster-Hauser Syndrome whereby a woman is born without a womb, or acquired (for example, a hysterectomy performed secondary to obstetric haemorrhage). Currently, the only two options for these women with regards to managing their infertility are surrogacy or adoption. Potentially, these women may also benefit from a possible future third option: womb transplantation. The UK team has been performing on-going research on this subject for the past 18 years, involving both animal and human experiments.
This study, involving ten patients, will comprise the first UK cohort to undergo womb transplantation for the purpose of carrying a pregnancy. A womb transplant would involve a transplantation of a womb from a brain-stem dead, heart-beating donor into the pelvis of a chosen patient. The patient will be followed-up for a maximum of twelve months to ensure both patient well-being and graft viability. Graft viability is of the utmost importance as it will decide whether the graft is suitable to carry a pregnancy. During follow-up, the patient will therefore undergo various imaging investigations, blood tests, vaginal swabs, and cervical biopsies. After the follow-up period is complete, the patient will submit to in-vitro fertilisation of already stored, frozen embryos. If implantation is successful, the patient will undergo a closely monitored antenatal period, culminating in a caesarean section at 39-40 weeks gestation or earlier if indicated. Future pregnancies will follow a course as described above. Once the family is complete, a hysterectomy will be performed, either at the time of the caesarean section or afterwards. Finally the patient will take immunosuppression medication as long as the transplanted graft is inside the pelvis. The study will be conducted at Hammersmith Hospital, with fertility treatment taking place at The Lister Hospital, London.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1407
Date of REC Opinion
29 Sep 2015
REC opinion
Further Information Favourable Opinion