Ovarian Reserve Testing in Female Young Adult Cancer Survivors

NCT01421095 | Active Not Recruiting

• 1 other identifier: ORT study
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Infertility

Keywords

Fertility; adolescent; young adult; cancer survivors

Outcome Measures

Primary Outcomes (1)

• Return of menses

  Self reported via bleeding calenders

  3 months

Secondary Outcomes (4)

• Blood levels of FSH

  3 months

• Blood levels of estradiol

  3 months

• Blood levels of AMH

  3 months

• Blood levels of inhibin B

  3 months

Study Arms (1)

Basal Testing

EXPERIMENTAL

Drug: recombinant FSH

Interventions

recombinant FSH DRUG

Each participant will recieve recombinant FSH (150 IU) intravenously

Also known as: Gonal F

Basal Testing

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Estrogen receptor positive cancers

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moores Cancer Center

San Diego, California, 91351, United States

Location

MeSH Terms

Conditions

Neoplasms; Infertility

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• H. Irene Su, MD MSCE

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Reproductive Medicine

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: August 22, 2011
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (1)