Actively Recruiting
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
N/A
Total Duration
Researchers are studying fertility challenges in individuals with Turner Syndrome, galactosemia, premature ovarian insufficiency (POI), and variations in sex characteristics. The study aims to understand why these conditions lead to early loss of ovarian function and whether freezing gonadal tissue can help preserve fertility for future use. The investigation includes examining the number and quality of follicles and gametes in the tissue and exploring the underlying biological reasons for follicle loss using advanced genetic sequencing techniques. Participants include children and adolescents aged 2 to 35 years who meet various condition-specific criteria. They may undergo medical history screening, physical exams, blood tests, body measurements, and ultrasound imaging. Some participants will have surgery to remove gonadal tissue, which will be frozen and stored for fertility preservation and used for research. The tissue storage is funded by NIH for one year, after which participants may be responsible for ongoing costs. Follow-up care includes checkups six weeks after surgery and periodic visits or phone calls for up to 30 years. During the study, participants will complete surveys about quality of life and health, and researchers will track hormone levels and analyze tissue samples before and after freezing. The study will monitor surgical outcomes and long-term effects of tissue freezing. Researchers will also develop a national database to better understand outcomes and explore treatments to improve follicle preservation. Participation involves extensive evaluations, long-term follow-up, and contributes to advancing knowledge on fertility preservation in these conditions.
CONDITIONS
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo gonadectomy or gonadal tissue removal for fertility preservation and tissue collection for research.
1 surgery visit and immediate post-operative observation
Duration - Up to several weeks post-surgery
Participants are monitored for surgical recovery and any complications following tissue removal.
Approximately 2 to 3 follow-up visits
Duration - Ongoing during and after tissue collection
Collected gonadal tissue is analyzed before and after cryopreservation to evaluate follicle and gamete quality, and research studies are conducted including next generation sequencing and treatment with inhibitors and activators.
No participant visits required during this stage
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
V
Veronica Gomez-Lobo, M.D.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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Ethics Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org
https://pubmed.ncbi.nlm.nih.gov/30098684Francisca Martinez, International Society for Fertility Preservation–ESHRE–ASRM Expert Working Group
https://pubmed.ncbi.nlm.nih.gov/28739117Signe Taasti Andersen, Susanne Elisabeth Pors, Liv la Cour Poulsen...
https://pubmed.ncbi.nlm.nih.gov/31594631