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Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01421095
Enrollment
34
Registered
2011-08-22
Start date
2011-01-01
Completion date
2026-12-31
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Infertility

Keywords

Fertility, adolescent, young adult, cancer survivors

Brief summary

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.

Detailed description

Same as brief summary

Interventions

Each participant will recieve recombinant FSH (150 IU) intravenously

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Postmenarchal * Cancer diagnosis * Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy * A minimum of 1 year since completion of gonoadotoxic therapy * Intact uterus * At least one ovary

Exclusion criteria

* Estrogen receptor positive cancers

Design outcomes

Primary

MeasureTime frameDescription
Return of menses3 monthsSelf reported via bleeding calenders

Secondary

MeasureTime frame
Blood levels of inhibin B3 months
Blood levels of FSH3 months
Blood levels of estradiol3 months
Blood levels of AMH3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026