IMAGEN, Version 1
Research type
Research Study
Full title
The impact of androgens on endometrial health
IRAS ID
279767
Contact name
Jacqueline Maybin
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Gender reassignment procedures alter a transgender person's physical appearance and/or the function of their existing sexual characteristics to resemble that socially associated with their identified gender. It is part of a treatment for gender dysphoria in transgender people.
For those wishing to transition to male gender, this involves administration of androgens (hormones) to facilitate development of male secondary sexual characteristics. Many of these individuals will then opt to have a hysterectomy procedure (removal of uterus) with removal of their ovaries and Fallopian tubes.
Androgen hormone receptors are present in the endometrium (lining of the womb). Androgens are known to have an important role in cell growth and cell repair in the endometrium, and also in establishment of pregnancy. However the effect of high doses of androgens on the health of the uterus is not fully understood.
The high dose androgen therapy used during gender reassignment may impact endometrial health. Data are required to establish the effects of these androgens on endometrial function to ensure safety, particularly for those who opt to delay or cancel hysterectomy procedures. In addition, the endometrium exposed to these high levels of androgens will inform our studies on endometrial function, providing important high dose androgen-exposed endometrium to compare with endometrium from those not taking hormones. This will provide high-quality in vivo data on the role of androgens in endometrial physiology.
People undergoing hysterectomy procedures as part of their female-to-male gender reassignment, or undergoing a hysterectomy for benign conditions, will be asked to participate. With informed consent, pipelle samples and/or “wedge” samples of endometrium and the underlying muscle layer will be taken from the uterus after removal. The study will not alter the surgical procedure in any way.
REC name
London - Bromley Research Ethics Committee
REC reference
20/PR/0448
Date of REC Opinion
20 Nov 2020
REC opinion
Further Information Favourable Opinion