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Ovarian Reserve Testing in Female Young Adult Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01421095
Recruitment Status : Recruiting
First Posted : August 22, 2011
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego

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.


Condition or disease Intervention/treatment
Cancer Infertility Drug: recombinant FSH

Detailed Description:
Same as brief summary

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Study Start Date : January 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Basal Testing Drug: recombinant FSH
Each participant will recieve recombinant FSH (150 IU) intravenously
Other Name: Gonal F



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


Secondary Outcome Measures :
  1. Blood levels of FSH [ Time Frame: 3 months ]
  2. Blood levels of estradiol [ Time Frame: 3 months ]
  3. Blood levels of AMH [ Time Frame: 3 months ]
  4. Blood levels of inhibin B [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Hui-Chun Irene Su, University of California, San Diego:
Fertility
adolescent
young adult
cancer survivors

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