Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Study Overview
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Brief Summary
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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
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Same as brief summary

Official Title
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Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Conditions
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Cancer, Infertility

Intervention / Treatment
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* Drug: recombinant FSH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal Testing<br> | Drug: recombinant FSH<br>* Each participant will recieve recombinant FSH (150 IU) intravenously<br>* Other names: Gonal F;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of menses | Self reported via bleeding calenders | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertility, adolescent, young adult, cancer survivors