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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how well young female cancer survivors can predict the return of normal menstrual cycles after cancer treatment. The researchers will compare different methods of testing ovarian reserve, which refers to the number and quality of eggs a woman has left, between cancer survivors and healthy individuals. Participants will undergo blood tests and ultrasounds to assess their ovarian reserve. Women who have undergone cancer treatments affecting fertility, such as certain chemotherapies, and have at least one ovary may be suitable for this study. As an unphased study, this trial offers participants the chance to contribute to valuable research that could enhance fertility assessments for cancer survivors.

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 prior data suggests that ovarian reserve testing is safe for young adult cancer survivors?

Research has shown that ovarian reserve testing, which includes blood tests and ultrasounds, is generally safe for participants. This testing helps assess fertility potential, particularly for women who have undergone cancer treatments. Studies have found that these tests are well-tolerated and do not pose significant risks.

The use of recombinant FSH, a hormone that aids egg growth in the ovaries, is also common in ovarian testing and considered safe. Notably, recombinant FSH has already been approved for other fertility treatments, indicating its well-established safety.

Overall, existing safety data supports the procedures and substances used in this testing, reducing concerns for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ovarian reserve testing for infertility in cancer survivors because it offers a more comprehensive way to understand fertility potential after cancer treatment. Unlike standard fertility assessments that might rely solely on hormone levels, this approach combines basal and provocative ovarian reserve testing with detailed pelvic ultrasounds and blood draws to get a clearer picture of ovarian function. This method could provide more personalized insights and help tailor fertility preservation strategies, which is crucial for cancer survivors looking to start or expand their families.

What evidence suggests that ovarian reserve testing is effective for assessing fertility potential in young adult cancer survivors?

Research has shown that certain tests, like those studied in this trial, can help predict whether young adult cancer survivors will resume menstruation. These tests might also provide insights into fertility by assessing the number and health of remaining eggs. Some studies have found that women with cancer may have lower levels of these fertility markers even before treatment begins. Although further research is necessary, these tests could play a crucial role in managing fertility concerns for cancer survivors. ^{1 6 7 8 9}

Who Is on the Research Team?

H. Irene Su, MD MSCE

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01421095

Ovarian Reserve Testing in Female Young Adult Cancer ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40780421/

Infertility evaluation and treatment in cancer survivors Although outcomes data remain limited, early evidence suggests that clinical pregnancy and live birth rates in this population can be favorable, ...

3. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT01421095

Ovarian Reserve Testing in Female Young Adult Cancer ... The purpose of this study is to test if basal and provocative ovarian reserve testing ... cancer survivors, Neoplasms, follitropin alfa ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10266964/

Ovarian reserve in reproductive-aged patients with cancer ... Our study revealed that women with cancer may have decreased ovarian reserve markers even before cancer therapy.

5. withpower.com withpower.com/clinical-trials/for-fertility

Top Fertility Clinical Trials | Power 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 ...

6. withpower.com withpower.com/trial/phase-infertility-2011-d9663

Ovarian Reserve Testing 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 ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.01885

Cancer Treatment-Related Ovarian Dysfunction in Women ... Baseline ovarian reserve testing is recommended for all WCBP who are receiving treatment for a cancer diagnosis to assess future fertility and ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK279058/

Ovarian Reserve Testing - Endotext - NCBI Bookshelf - NIH Efficient and effective ovarian testing can give women valuable answers about their fertility, time to menopause, and other conditions and symptoms they may ...

9. asrm.org asrm.org/practice-guidance/practice-committee-documents/testing-and-interpreting-measures-of-ovarian-reserve-a-committee-opinion-2020/

Testing and interpreting measures of ovarian reserve: a ... Results of ovarian reserve tests are not useful in predicting the likelihood of unassisted pregnancy in women with infertility, nor do they offer clinically ...