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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
Must not have
Estrogen receptor positive cancers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I have started menstruating.
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I have had treatments that could affect my reproductive organs.
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I have at least one ovary.
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I have an intact uterus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is estrogen receptor positive.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Return of menses

Side effects data

From 2017 Phase 4 trial • 620 Patients • NCT02554279
23%
Procedural pain
12%
Nausea
10%
Ovarian hyperstimulation syndrome
9%
Headache
8%
Abdominal distension
7%
Abdominal pain
7%
Vaginal haemorrhage
7%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Menotropin
Recombinant FSH

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,707 Total Patients Enrolled
4 Trials studying Infertility
3,291 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
~4 spots leftby Dec 2026
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