Ovarian Reserve Testing in Female Young Adult Cancer Survivors

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2026 → Dec 2028
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Record History

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  1. Notable Primary and study completion pushed from Dec 2026 to Dec 2028
    • Eligibility criteria expanded, about 7 words
  2. Notable Primary and study completion dates: Dec 2025 to Dec 2026v13
  3. Minor 2 versions Re-verified since Aug 9, 2022, no change to tracked fieldsv11-v12
  4. Notable Primary and study completion dates: Dec 2022 to Dec 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v10
  5. Notable Primary and study completion dates: Dec 2020 to Dec 2022
    • Start date: Jan 2011 to Jan 1, 2011
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv8
  2. Notable Primary and study completion dates: Dec 2016 to Dec 2020v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Primary completion date: Dec 2014 to Dec 2016v5
  5. Minor Re-verified, no change to tracked fieldsv4
  6. Notable Primary completion date: Dec 2012 to Dec 2014
    • Study completion date: Dec 2014 to Dec 2016
    v3
  7. Minor Study completion date: Dec 2012 to Dec 2014
    • Secondary endpoints: 1 to 4
    v2
  1. Minor Study First Submitted
  • 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.
Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products. Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.
Trial Details
NCT Number NCT01421095
Lead Sponsor University of California, San Diego
Conditions
(from sponsor)
Cancer, Infertility
Related terms Infertility, Neoplasms
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov