Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS

NCT03252223 | Completed Phase 4 FDA Drug

• 3 other identifiers: 170684P50HD012303K12HD001259
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 seemingly requires prolonged administration compared to that of ovulatory women without PCOS. The apparent differing ovarian responsiveness to FSH between PCOS and normal women has not been carefully studied. We propose to address this issue by performing a dose-response study and examine ovarian follicle (estrogen, E2) responses to FSH administered subcutaneously in women with PCOS compared to responses observed in normal women.

Conditions

Polycystic Ovary Syndrome; Healthy; Anovulation; Hyperandrogenism

Keywords

polycystic ovary syndrome; anovulation; hyperandrogenism

Outcome Measures

Primary Outcomes (3)

• Change in granulosa cell function in 24 hours intervals following FSH administration

  Granulosa function will be assessed using estradiol and inhibin levels

  Serum levels will be assessed daily during each 3 day FSH stimulation test and for five days following the initial FSH administration

• Change in follicle count in following FSH administration

  Number of ovarian follicles will be assessed by pelvic ultrasound

  With each dose tested, a pelvic ultrasound will be done before and 3 days after commencing FSH

• Change in follicular size in following FSH administration

  Size of ovarian follicles will be assessed by pelvic ultrasound

  With each dose tested, a pelvic ultrasound will be done before and 3 days after commencing FSH

Study Arms (2)

Women with normal menses

ACTIVE COMPARATOR

Drug: Recombinant Follicle Stimulating Hormone

Women with Polycystic Ovary Syndrome

ACTIVE COMPARATOR

Drug: Recombinant Follicle Stimulating Hormone

Interventions

Recombinant Follicle Stimulating Hormone DRUG

A modified dose-response study will be done using recombinant FSH (r-FSH), injected sc for 3 days at any one dose. r-FSH will be administered at weight-adjusted doses equivalent to 37.5, 75, and 150 IU based on an average weight of 70 kg, which approximates the weight of the average woman in the United States according to the Centers for Disease Control. Therefore, the actual dose of r-FSH will be 0.53 IU/kg for the 37.5 dose group. Accordingly, r-FSH will be repeated at doses of 1.1 IU/kg and 2.2 IU/kg that are equivalent to 75 and 150 IU for a 70 kg subject. Each FSH stimulation test will be assigned randomly and be separated by an interval of 8 weeks.

Women with Polycystic Ovary Syndrome; Women with normal menses

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Anovulation; Hyperandrogenism

Interventions

Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• R. Jeffrey Chang, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 17, 2017
• Study Start: October 2, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)