Ovarian Reserve Testing in Female Young Adult Cancer Survivors

NCT ID: NCT01421095

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2026-12-31

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

Conditions

Cancer; Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Basal Testing

Group Type: EXPERIMENTAL

recombinant FSH

Intervention Type: DRUG

Each participant will recieve recombinant FSH (150 IU) intravenously

Interventions

recombinant FSH

Each participant will recieve recombinant FSH (150 IU) intravenously

Intervention Type: DRUG

Other Intervention Names

Gonal F

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Hui-Chun Irene Su

Assistant Professor of Reproductive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H. Irene Su, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

UCSD Moores Cancer Center

San Diego, California, United States

Countries

United States

Other Identifiers

ORT study

Identifier Type: -

Identifier Source: org_study_id