Actively Recruiting
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2026-05-01
200
Participants Needed
1
Research Sites
463 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with Turner Syndrome prior to menarche aged 2 to 12 years seeking ovarian tissue storage
- Individuals with galactosemia aged 2 to 21 years
- Post-menarcheal adolescent females up to 21 years diagnosed with premature ovarian insufficiency within 2 years
- Children or adolescents aged 2 to 24 years with diminished ovarian reserve or poor response to ovarian stimulation
- Individuals with variations in sex characteristics including Turner syndrome with Y chromosome material undergoing gonadectomy
- Individuals aged 2 to 35 years receiving high-risk gonadotoxic therapy at high risk for POI and infertility
- Willingness to comply with study procedures and availability for study duration
- Ability to understand and sign informed consent by subject, parent, or guardian
You will not qualify if you...
- Individuals older than 7 years with psychological or psychiatric conditions preventing informed consent
- Presence of pelvic mass tumor on pre-operative ultrasound
- Medical conditions significantly increasing risk from anesthesia or surgery
- Females with POI due to chemotherapy or radiation
- Pregnancy or lactation
- Individuals with variations in sex characteristics who choose to retain gonads
- Individuals with Turner Syndrome with undetectable AMH levels based on lab reference
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
V
Veronica Gomez-Lobo, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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