INSITU study
Research type
Research Study
Full title
INvestigational Study Into Transplantation of the Uterus (INSITU)
IRAS ID
235711
Contact name
J. Richard Smith
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Absolute uterine factor infertility (AUFI) is a condition that affects one in 500 women of childbearing age. AUFI refers to women with infertility secondary to either the absence of a uterus or the presence of an anatomically or physiologically non-functioning uterus. The current options to acquire motherhood include adoption or surrogacy. Not only are these options associated with complex legal, financial, cultural, ethical and religious factors, but a woman’s inability to conceive, carry pregnancy and ultimately bear children negatively affects the perception of their own femininity and quality of living. Moreover, greater than a third of infertile women suffer with severe symptoms of depression and they have a two-fold increased risk of suicide. Uterine transplantation (UTx) gives women with AUFI the opportunity to conceive, carry pregnancy and bear biologically related children, but in addition may also improve their psychological wellbeing. \n\nThis study will comprise the first UK cohort to undergo UTx with the ultimate aim of carrying a pregnancy and having a successful livebirth. All recipients will undergo a period of counselling and pre-operative investigation to ensure they are suitable. Fertility treatment including embryo cryopreservation of at least ten embryos will subsequently be undertaken in each participant prior to being placed on a waiting list until a suitable brain stem dead, heart being donor becomes available. Once a donor is identified, the transplant will take place. Post-operatively the recipient will take aspirin and immunosuppressive therapy. Embryo transfer will commence six months after transplantation, subject to an uncomplicated course. Following conception, high risk antenatal care would ensue with delivery by Caesarean Section between 35-37 weeks’ gestation. The process could be repeated for another child if desired by the recipient and was clinically appropriate. Hysterectomy would be planned six months following the completion of the woman’s family. \n
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0217
Date of REC Opinion
28 Feb 2018
REC opinion
Further Information Favourable Opinion