Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction… (NCT04948658) | Clinical Trial Compass
RecruitingNot Applicable
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
United States200 participantsStarted 2021-09-13
Plain-language summary
Background:
Turner Syndrome, galactosemia, and premature ovarian insufficiency are all conditions that may make it very hard or impossible for a person to become pregnant and have their own child. Researchers want to learn more about why this happens and if freezing Gonadal tissue allows for fertility preservation.
Objective:
To find out why people with certain conditions have can have premature ovarian insufficiency (POI or early menopause) and individuals with variations in sex characteristics have trouble getting pregnant and if freezing the gonads tissue from them will help to have their own child in the future.
Eligibility:
Individuals aged 2-21 who have Turner Syndrome or galactosemia. Also, females aged 13-21 with premature ovarian insufficiency, individuals with variations in sex characteristics, and individuals 2-35 receiving high-risk gonadotoxic therapy
Design:
Participants will be screened with a medical history.
Participants may have a physical exam and blood tests. Their body measurements may be taken. These include weight, height, arm span, skin fold, and sitting height. They may fill out surveys about their quality of life, body image, and health.
Participants may have a transabdominal pelvic ultrasound. A probe will be placed on their belly and will take pictures of the organs in the pelvis. They may have a transvaginal pelvic ultrasound performed while asleep in the operating room if needed.
Participants may have surgery to remove an gonads and skin biopsy. The removed tissue will be frozen and stored. The tissue will have to be stored for many years. NIH will pay to store the tissue for 1 year. After that, participants will have to pay for storage.
A piece of the gonads (no more than 20%) will be used for research
Travel, lodging and meals for participants traveling greater than 50 miles will be reimbursed based off the government rate. Local participants will not be reimbursed.
Participants will have a checkup 6 weeks after surgery one or more follow-up visits 6-18 months after surgery. They may have phone follow-up every 12-24 months after surgery.
Participation will last 30 years.
Who can participate
Age range
2 Years – 35 Years
Sex
ALL
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
. Individuals with Turner Syndrome prior to menarche aged 2 years to 12 years whose families seek to store ovarian tissue for possible future use.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Ability of subject, parents, or guardian to understand and the willingness to sign a written informed consent document.
Exclusion criteria
. Individuals older than 7 years with psychological, psychiatric, or other conditions which prevent giving fully informed consent or assent.
. Individuals with a pelvic mass tumor noted on pre-operative ultrasound, will undergo usual care for the underlying condition and will not undergo oophorectomy for ovarian tissue cryopreservation.
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.
1Since this trial involves freezing gonadal tissue rather than testing a new drug or treatment, can you help me understand whether the tissue collected would primarily be used for research purposes, or whether there's also a realistic path toward using it for my own future fertility?
2Given that this trial enrolls people with conditions like Turner Syndrome, galactosemia, and differences in sex development, how does my specific diagnosis affect whether gonadal tissue freezing might actually be useful for me versus someone with a different condition on this list?
3This trial is listed as 'Phase NA,' which suggests it's not a standard drug trial — so what are the main risks involved in the tissue collection procedure itself, and how does that weigh against the potential benefit of preserving fertility options?
4Because the trial is collecting tissue for RNA sequencing and research, can you clarify what happens to my tissue long-term, who has access to it, and whether I would have any say in how it's used in the future?
5Are there standard fertility preservation options I should consider first, or alongside this trial, so I can compare what's already available clinically versus what this research protocol offers?
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
Single cell/nucleus RNA sequencing
Timeframe: before and after cryopreservation
2
Tissue for research
Timeframe: before and after cryopreservation
Trial details
NCT IDNCT04948658
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)