Ovarian Reserve Testing in Female Young Adult Cancer Survivors

October 14, 2023 updated by: Hui-Chun Irene Su, University of California, San Diego

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Same as brief summary

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 91351
        • UCSD Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basal Testing
Drug: recombinant FSH
Each participant will recieve recombinant FSH (150 IU) intravenously
Other Names:
  • Gonal F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return of menses
Time Frame: 3 months
Self reported via bleeding calenders
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood levels of FSH
Time Frame: 3 months
3 months
Blood levels of estradiol
Time Frame: 3 months
3 months
Blood levels of AMH
Time Frame: 3 months
3 months
Blood levels of inhibin B
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: H. Irene Su, MD MSCE, UC San Diego

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 Major Dates

Study Start

January 1, 2011

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimated)

August 22, 2011

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORT study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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