Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Primary Purpose
Cancer, Infertility
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
recombinant FSH
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer focused on measuring Fertility, adolescent, young adult, cancer survivors
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
Sites / Locations
- UCSD Moores Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Basal Testing
Arm Description
Outcomes
Primary Outcome Measures
Return of menses
Self reported via bleeding calenders
Secondary Outcome Measures
Blood levels of FSH
Blood levels of estradiol
Blood levels of AMH
Blood levels of inhibin B
Full Information
NCT ID
NCT01421095
First Posted
June 15, 2011
Last Updated
October 14, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01421095
Brief Title
Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Official Title
Ovarian Reserve Testing in Female Young Adult Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2011 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Infertility
Keywords
Fertility, adolescent, young adult, cancer survivors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Basal Testing
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
recombinant FSH
Other Intervention Name(s)
Gonal F
Intervention Description
Each participant will recieve recombinant FSH (150 IU) intravenously
Primary Outcome Measure Information:
Title
Return of menses
Description
Self reported via bleeding calenders
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood levels of FSH
Time Frame
3 months
Title
Blood levels of estradiol
Time Frame
3 months
Title
Blood levels of AMH
Time Frame
3 months
Title
Blood levels of inhibin B
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Irene Su, MD MSCE
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
91351
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ovarian Reserve Testing in Female Young Adult Cancer Survivors
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