Status:
COMPLETED
Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Healthy
Eligibility:
FEMALE
18-37 years
Phase:
PHASE4
Brief Summary
Women with PCOS suffer from anovulation and, as a result, infertility. Efforts to clinically induce ovulation in these women using follicle stimulating hormone (FSH) administered subcutaneously seemin...
Detailed Description
In women with polycystic ovary syndrome (PCOS) androgen excess is fundamental to the clinical and physiological alterations of this disorder. In particular, androgen overproduction induces distinctive...
Eligibility Criteria
Inclusion
- Subjects determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound OR
- Subjects determined to have a clinical history of regular periods.
Exclusion
- Women with hemoglobin less than 11 gm/dl at screening evaluation
- Women with untreated thyroid abnormalities
- Pregnant women or women who are nursing
- Women with BMI \> 37
- Women with known sensitivity to the agents being used
- Women with diabetes, or renal, liver, or heart disease
- Women with any hormonal therapy or metformin for at least 2 months prior to study start.
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03252223
Start Date
October 2 2017
End Date
June 30 2021
Last Update
September 8 2021
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92037