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Ovarian Reserve Testing in Female Young Adult Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by University of California, San Diego
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego Identifier:
First received: June 15, 2011
Last updated: May 2, 2017
Last verified: May 2017

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.

Condition Intervention
Drug: recombinant FSH

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Return of menses [ Time Frame: 3 months ]
    Self reported via bleeding calenders

Secondary Outcome Measures:
  • Blood levels of FSH [ Time Frame: 3 months ]
  • Blood levels of estradiol [ Time Frame: 3 months ]
  • Blood levels of AMH [ Time Frame: 3 months ]
  • Blood levels of inhibin B [ Time Frame: 3 months ]

Estimated Enrollment: 34
Study Start Date: January 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basal Testing Drug: recombinant FSH
Each participant will recieve recombinant FSH (150 IU) intravenously
Other Name: Gonal F

Detailed Description:
Same as brief summary

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01421095

Contact: Samantha C Bailey 858-822-0768

United States, California
UCSD Moores Cancer Center Recruiting
San Diego, California, United States, 91351
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: H. Irene Su, MD MSCE UC San Diego
  More Information

Responsible Party: Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego Identifier: NCT01421095     History of Changes
Other Study ID Numbers: ORT study
Study First Received: June 15, 2011
Last Updated: May 2, 2017

Keywords provided by University of California, San Diego:
young adult
cancer survivors

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 25, 2017