Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy (NCT05863676) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy
United States20 participantsStarted 2020-07-14
Plain-language summary
The goal of this study is to learn about fertility preservation in the gender-diverse community. The main objectives it aims to understand are to:
1. To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
2. To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy
Who can participate
Age range
9 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:Two Categories of participants will be eligible for this study.
Category 1 participants must have all criteria listed below:
* Patient with ovaries over the age of 9
* Diagnosed with gender dysphoria; currently on or imminently planning to start gender affirming treatment (hormone blockers or gender-affirming hormones)
* Have a clinical referral for fertility preservation from their primary care physician
* Unwilling to undergo natal puberty or, for patients who have gone through puberty, unwilling to discontinue hormone suppression and/or hormone replacement therapy.
Category 2 participants only fall into this category if they are undergoing gender-affirming surgery. They must have all criteria listed below:
* Patient is 18+ years old
* Diagnosed with gender dysphoria
* Unwilling to undergo natal puberty, or for patients who have gone through puberty, be unwilling to discontinue hormone suppression and/or sex steroid (estrogen) therapy.
* Will be undergoing gender affirming surgery that involves removal of the ovaries.
Exclusion Criteria:
* Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
* Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
Timeframe: [10 years]
2
To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy.