Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Background: Medical advances have improved survival rates for many cancers and other illnesses. This means that more people are coping with the long-term effects of these treatments. Some treatments can cause female infertility. Ovarian tissue cryopreservation (OTC) may help. Before undergoing a treatment that may damage their fertility, patients may opt to freeze a sample of ovarian tissue. The tissue contains immature egg cells. When thawed, the tissue can be reimplanted. This procedure can help women become pregnant. Objective: This natural history study will create a databank of ovarian tissue. The NIH will provide OTC as a clinical service. The NIH will also request a portion of the tissue to use for research. Eligibility: Females aged 4 to 35 who opt to have OTC before receiving cancer treatment. Design: Participants will be screened. Their existing medical records will be reviewed. They will be asked if they want to donate a portion of their ovarian tissue for research. No more than 20% of the tissue collected will be taken for research. Some other tissues that would otherwise be discarded will also be kept. Medical data from each participant may also be collected and stored in the database. This data may include results of routine blood tests, imaging tests, and other information. The data will be coded for privacy. Participants will answer a questionnaire. They will be asked about their fertility treatment and general health. The survey takes about 30 minutes. They will repeat the questionnaire once a year for 30 years.
Conditions:
🦠 Acute Ovarian Failure 🦠 Infertility 🦠 Early Menopause And Infertility In Females After Treatment For Childhood Cancer
🗓️ Study Start (Actual) 22 July 2022
🗓️ Primary Completion (Estimated) 21 September 2041
✅ Study Completion (Estimated) 21 September 2041
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
    • * Provision of signed and dated informed consent/assent form.
    • * Stated willingness to comply with all study procedures and availability for the duration of the study.
    • * Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care.

    Exclusion Criteria:

    • -An individual who meets any of the following criteria will be excluded from participation in this study:
    • --Adults subjects with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
Ages Eligible for Study: 4 Years to 35 Years (CHILD, ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 June 2022
  • First Submitted that Met QC Criteria 30 June 2022
  • First Posted 1 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 July 2024
  • Last Update Posted 15 July 2024
  • Last Verified 8 July 2024