Assessing the effectiveness of transplanting ovarian tissue
Research type
Research Study
Full title
Ovarian transplantation for preserving endocrine and reproductive function
IRAS ID
246841
Contact name
Arri Coomarasamy
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Aims:
To assess the effectiveness of ovarian tissue transplantation.Relevance
Many women undergo surgery for removal of their ovaries or a significant part of the ovaries for non-malignant indications e.g. endometriosis and ovarian cysts. This can sometimes also be accompanied with removal of their womb. Consequently, total or significant loss of ovarian function can occur and cause premature menopause and permanent fertility loss with significant compromise on the quality of life.What is being studied?
A new procedure at the Birmingham Women's Hospital involves transplanting strips of a patient’s own healthy ovarian tissue. The ovarian tissue is transplanted in one of the three sites; the lining of their pelvis, under the skin (subdermal) in the abdomen or arm and on top of the vagina. From previous evidence we would expect these transplants to restore hormonal levels to normal within 4-6 months for 5-7 years. This could reduce the need for hormone replacement therapy and make pregnancy possible if desired.
My study will involve analyzing the routine blood test results and ultra sound scans of these patients. This will accompany a questionnaire based assessment of their quality of life.Who would be eligible?
Female patients
18-40 years old
Not suffering from menopause.
Undergoing removal of both the ovaries (and/or womb).The type of sites where the study will be conducted:
The study will be conducted in Birmingham Women’s Hospital (Birmingham Women’s and Children’s NHS Trust).How long will the study last and what will the participants undergo?
The study will last for 2 years and the participants will be requested to consent to take part and complete a quality of life questionnaire.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0338
Date of REC Opinion
9 Nov 2018
REC opinion
Further Information Favourable Opinion