← Back to Search

Ovarian Reserve Testing for Infertility in Cancer Survivors

N/A

Waitlist Available

Led By H. Irene Su, MD MSCE

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenarchal

Prior exposure to gonadotoxic therapy, inclusive of chemotherapy, pelvic or total body irradiation, unilateral oophorectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing if two measures of ovarian reserve - blood draws and pelvic ultrasounds - can accurately predict if a young adult cancer survivor will experience a return of menses. The trial will also compare the results of the ovarian reserve measures between cancer survivors and healthy controls, and between cancer survivors taking and not taking combined estrogen and progesterone hormone products.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

There may not be direct side effects from the interventions since they involve diagnostic testing rather than medication; however, stopping birth control could lead to changes in menstrual cycle patterns or a temporary increase in fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have started menstruating.

Select...

I have had treatments that could affect my reproductive organs.

Select...

I have at least one ovary.

Select...

I have an intact uterus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Return of menses

Secondary outcome measures

Blood levels of AMH

Blood levels of FSH

Blood levels of estradiol

+1 more

Side effects data

From 2017 Phase 4 trial • 620 Patients • NCT02554279

23%

Procedural pain

12%

Nausea

10%

Ovarian hyperstimulation syndrome

Headache

Abdominal distension

Vaginal haemorrhage

Abdominal pain

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Menotropin

Recombinant FSH

Trial Design

1Treatment groups

Experimental Treatment

Group I: Basal TestingExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

recombinant FSH

2013

Completed Phase 4

~1190

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,601 Total Patients Enrolled

2 Trials studying Infertility

261 Patients Enrolled for Infertility

H. Irene Su, MD MSCEPrincipal InvestigatorUC San Diego

2 Previous Clinical Trials

403 Total Patients Enrolled

1 Trials studying Infertility

221 Patients Enrolled for Infertility

Media Library

recombinant FSH Clinical Trial Eligibility Overview. Trial Name: NCT01421095 — N/A

Infertility Research Study Groups: Basal Testing

Infertility Clinical Trial 2023: recombinant FSH Highlights & Side Effects. Trial Name: NCT01421095 — N/A

recombinant FSH 2023 Treatment Timeline for Medical Study. Trial Name: NCT01421095 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the criteria to apply for participation in this experiment?

"This trial is seeking 34 participants, aged 18 to 35 years old, who have been diagnosed with cancer. Applicants must also meet the following criteria: having undergone gonadotoxic therapy within one year of enrollment; prior exposure to chemotherapies, pelvic or total body radiation treatments, and unilateral oophorectomy; postmenarchal status; and possession of at least one ovary."

Answered by AI

Does this research extend to participants of 20 years or older?

"This medical trial is seeking between 18 and 35 year old participants. Patients younger than 18 and those older than 65 can find appropriate care in the 74 studies available to them or the 465 trials targeting their age group, respectively."

Answered by AI

Are there opportunities for individuals to volunteer for this research endeavor?

"The clinicaltrials.gov platform states that this trial is no longer enrolling patients, having first been posted on January 1st 2011 and last updated on August 9th 2022. Despite this fact, there are 729 other medical trials requiring participants at the current moment in time."

Answered by AI