Ovarian Reserve Testing in Female Young Adult Cancer Survivors

This study is currently recruiting participants.
Verified April 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01421095
First received: June 15, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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
Cancer
Infertility
Drug: recombinant FSH

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Return of menses [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self reported via bleeding calenders


Secondary Outcome Measures:
  • Blood levels of FSH [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood levels of estradiol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood levels of AMH [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood levels of inhibin B [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421095

Contacts
Contact: Samantha C Bailey 858-822-0768 ayastudy.ucsd@gmail.com

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

No publications provided

Responsible Party: Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01421095     History of Changes
Other Study ID Numbers: ORT study
Study First Received: June 15, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014