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Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 193 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 5 words
  3. Minor 11 versions Re-verified since Feb 19, 2026, no change to tracked fieldsv181-v191
  4. Minor Eligibility criteria expanded, about 4 wordsv180
  5. Minor Re-verified, no change to tracked fieldsv179
Show 35 earlier versionsHide 35 earlier versions
  1. Notable Enrollment target: 100 to 200
    • Study description expanded, about 29 words
    v178
  2. Minor Re-verified, no change to tracked fieldsv177
  3. Minor Study arms: 5 to 6v176
  4. Minor Eligibility criteria expanded, about 25 words
    • Study description expanded, about 6 words
    v175
  5. Minor 5 versions Re-verified since May 17, 2025, no change to tracked fieldsv170-v174
  6. Minor Eligibility criteria expanded, about 15 wordsv169
  7. Minor Study description revisedv168
  8. Minor Eligibility criteria expanded, about 4 wordsv167
  9. Minor 11 versions Re-verified since Jun 8, 2024, no change to tracked fieldsv156-v166
  10. Minor Study description expanded, about 80 wordsv155
  11. Minor Eligibility criteria shortened, about 5 wordsv154
  12. Minor 5 versions Re-verified since Oct 18, 2023, no change to tracked fieldsv149-v153
  13. Minor Study arms: 4 to 5v148
  14. Minor Study Status, Study Description, Eligibilityv147
  15. Minor 3 versions Re-verified since Apr 1, 2023, no change to tracked fieldsv144-v146
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04948658
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Turner Syndrome, Post-menarcheal Adolescents, Ovarian Disfunction, Galactosemia, Variations in Sex Characteristics, Differences in Sex Development
Related terms Galactosemias, Turner Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov