Ovarian Reserve Testing for Infertility in Cancer Survivors

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Birth control

Disqualifiers: Estrogen receptor positive cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

34 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking birth control pills, patches, or a vaginal ring, you will need to stop using them for 3 months during the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Basal and Provocative Ovarian Reserve Testing, Blood Draws, Pelvic Ultrasounds, Recombinant FSH for infertility in cancer survivors?

Ovarian reserve tests, which include blood tests and ultrasounds, help estimate a woman's remaining egg supply and her response to fertility treatments. These tests are particularly useful for cancer survivors, as they can indicate changes in ovarian function due to cancer treatments, although more research is needed to fully understand their predictive value for fertility outcomes. ^{1 2 3 4 5}

Is ovarian reserve testing safe for cancer survivors?

Ovarian reserve testing, which includes blood tests and pelvic ultrasounds, is generally considered safe for assessing fertility potential. However, specific safety data for cancer survivors is limited, and more research is needed to fully understand its safety in this group. ^{1 2 5 6 7}

How is ovarian reserve testing unique for infertility in cancer survivors?

Ovarian reserve testing is unique for infertility in cancer survivors because it helps assess the impact of cancer treatments on a woman's remaining egg supply and fertility potential. This testing is crucial as cancer treatments can significantly affect ovarian function, and understanding the ovarian reserve can guide fertility preservation and treatment decisions. ^{1 2 3 8 9}

What is the purpose of this trial?

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.

Research Team

H. Irene Su, MD MSCE

Principal Investigator

UC San Diego

Eligibility Criteria

This trial is for young adult female cancer survivors who are postmenarchal, have at least one ovary and an intact uterus, and have undergone gonadotoxic therapy like chemotherapy or irradiation. They should be one year past their treatment completion. Those with estrogen receptor positive cancers cannot participate.

Inclusion Criteria

I have been diagnosed with cancer.

I have started menstruating.

I have had treatments that could affect my reproductive organs.

Exclusion Criteria

My cancer is estrogen receptor positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo ovarian reserve testing by blood draws and pelvic ultrasounds

1 week

1 visit (in-person)

Monitoring

Participants track their periods over three months and may come off birth control

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for return of menses and ovarian reserve

4 weeks

Treatment Details

Interventions

• Basal and Provocative Ovarian Reserve Testing
• Blood Draws
• Pelvic Ultrasounds
• Recombinant FSH

Trial Overview The study aims to see if ovarian reserve tests can predict the return of menstrual cycles in these survivors by comparing test results with healthy individuals. Participants will stop birth control methods, track periods for three months, and undergo blood tests and ultrasounds.

Participant Groups

Group I: Basal Testing Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Strategies for ascertaining ovarian reserve among women suspected of subfertility. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Ovarian reserve screening: what the general gynecologist should know. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Tests for ovarian reserve: reliability and utility. [2010]

4. Italy pubmed.ncbi.nlm.nih.gov

Measuring ovarian function in young cancer survivors. [2010]

5. England pubmed.ncbi.nlm.nih.gov

Fertility in female cancer survivors: pathophysiology, preservation and the role of ovarian reserve testing. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Performance of basal follicle-stimulating hormone in the prediction of poor ovarian response and failure to become pregnant after in vitro fertilization: a meta-analysis. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Adverse reproductive health outcomes in a cohort of young women with breast cancer exposed to systemic treatments. [2020]

8. France pubmed.ncbi.nlm.nih.gov

[How to assess ovarian reserve in 1999?]. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Predictors of ovarian reserve in young women with breast cancer. [2022]