Fertility Preservation by Freezing Gonadal Tissue in Children and Young Adults at Risk for Early Ovarian Failure or Undergoing Gonad Removal
Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2026-08-06
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying why people with Turner Syndrome, galactosemia, premature ovarian insufficiency POI, variations in sex characteristics, and those receiving high-risk gonadotoxic therapy have trouble getting pregnant or experience early menopause. The study aims to understand these conditions better and evaluate if freezing gonadal tissue can help preserve fertility in affected individuals. This observational study also explores the biological mechanisms causing follicle loss through advanced tissue analysis.
Participants may undergo physical exams, blood tests, body measurements, and pelvic ultrasounds. Some may have surgery to remove gonadal tissue, which will be frozen and stored for future use. A portion of this tissue will be used for research to study follicles and gametes before and after freezing. The study includes multiple groups children and adolescents with various conditions at risk for ovarian dysfunction, including those who respond poorly to ovarian stimulation and those undergoing prophylactic gonadectomy.
Participants will have follow-up visits including a checkup six weeks after surgery and additional visits up to 18 months post-surgery, with phone follow-ups every 12 to 24 months. Researchers will assess tissue quality, hormone levels, and gene expression to understand follicle loss and preservation. The study lasts 30 years, tracking long-term outcomes and potential complications related to fertility preservation and gonadal tissue cryopreservation.
CONDITIONS
Brief Title
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Research Team
V
Veronica Gomez-Lobo, M.D.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead Sponsor
Who Can Participate
Age: 2Years - 35Years
All Genders
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
Adolescent females up to 21 years old with premature ovarian insufficiency diagnosed within 2 years after menarche
Children or adolescents aged 2 to 24 years with diminished ovarian reserve or poor response to ovarian stimulation for egg freezing
Individuals with variations in sex characteristics including Turner syndrome with Y chromosome material undergoing prophylactic gonadectomy
Individuals aged 2 to 35 years receiving high-risk gonadotoxic therapy at high risk for premature ovarian insufficiency
Willingness to comply with all study procedures and availability for the study duration
Ability to understand and sign informed consent
You will not qualify if you...
Individuals older than 7 years with psychological or psychiatric conditions preventing informed consent or assent
Individuals with pelvic mass tumors who will not undergo oophorectomy for tissue cryopreservation
Individuals with medical conditions increasing risk from anesthesia or surgery
Females with premature ovarian insufficiency due to chemotherapy or radiation
Pregnancy or lactation
Individuals with variations in sex characteristics who choose to keep their gonads after consultation
Individuals with Turner Syndrome who have undetectable anti-Mullerian hormone levels
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Tissue Collection
Duration - Not specified
Participants may undergo surgery to remove gonadal tissue, which will be frozen and stored for fertility preservation and research.
Follow-up
Duration - Up to 30 years
Participants will have a checkup 6 weeks after surgery and additional follow-up visits 6 to 18 months after surgery, with phone check-ins every 12 to 24 months.
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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Published Research Related To This Trial
Update on fertility preservation from the Barcelona International Society for Fertility Preservation-ESHRE-ASRM 2015 expert meeting: indications, results and future perspectives.
Francisca Martinez, International Society for Fertility Preservation–ESHRE–ASRM Expert Working Group