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Clinical Trials/NCT01421095
NCT01421095
Active, not recruiting
Not Applicable

Ovarian Reserve Testing in Female Young Adult Cancer Survivors

University of California, San Diego1 site in 1 country34 target enrollmentJanuary 1, 2011

Overview

Phase
Not Applicable
Intervention
recombinant FSH
Conditions
Cancer
Sponsor
University of California, San Diego
Enrollment
34
Locations
1
Primary Endpoint
Return of menses
Status
Active, not recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2011
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hui-Chun Irene Su

Assistant Professor of Reproductive Medicine

University of California, San Diego

Eligibility Criteria

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

Arms & Interventions

Basal Testing

Intervention: recombinant FSH

Outcomes

Primary Outcomes

Return of menses

Time Frame: 3 months

Self reported via bleeding calenders

Secondary Outcomes

  • Blood levels of FSH(3 months)
  • Blood levels of AMH(3 months)
  • Blood levels of estradiol(3 months)
  • Blood levels of inhibin B(3 months)

Study Sites (1)

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