NCT02145247

Brief Summary

Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow and mature, there are more androgen producing cells. Women with PCOS have more follicles than normal women and therefore more androgen producing cells. While androgen production has been associated with the number of follicles, the relationship to the individual size of follicles in PCOS or normal women. This study intends to determine whether the size and number of ovarian follicles are correlated to androgen production in PCOS and normal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

May 20, 2014

Results QC Date

March 28, 2019

Last Update Submit

August 8, 2019

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Percent Change of 17-OHP Levels From Baseline

    On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms. Blood samples will be obtained before and after r-hCG adminstration

    before and 24 hours after adminisration of r-hCG

Study Arms (2)

Normal adult women

ACTIVE COMPARATOR

1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject. 2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms. 3. Blood samples will be obtained at T = -0.5, 0, and +24 hours. 4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production. 5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

Drug: hCG

Women with PCOS

ACTIVE COMPARATOR

1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject. 2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms. 3. Blood samples will be obtained at T = -0.5, 0, and +24 hours. 4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production. 5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

Drug: hCG

Interventions

hCGDRUG

3\. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms. 4\. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

Also known as: Re-combinant human choriogonadotropin
Normal adult womenWomen with PCOS

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound
  • Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start
  • Subjects will be determined to be normal controls if they 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Related Publications (4)

  • Rosencrantz MA, Coffler MS, Haggan A, Duke KB, Donohue MC, Shayya RF, Su HI, Chang RJ. Clinical evidence for predominance of delta-5 steroid production in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Apr;96(4):1106-13. doi: 10.1210/jc.2010-2200. Epub 2011 Jan 26.

    PMID: 21270326BACKGROUND

  • Pigny P, Jonard S, Robert Y, Dewailly D. Serum anti-Mullerian hormone as a surrogate for antral follicle count for definition of the polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Mar;91(3):941-5. doi: 10.1210/jc.2005-2076. Epub 2005 Dec 20.

    PMID: 16368745BACKGROUND

  • Dewailly D, Gronier H, Poncelet E, Robin G, Leroy M, Pigny P, Duhamel A, Catteau-Jonard S. Diagnosis of polycystic ovary syndrome (PCOS): revisiting the threshold values of follicle count on ultrasound and of the serum AMH level for the definition of polycystic ovaries. Hum Reprod. 2011 Nov;26(11):3123-9. doi: 10.1093/humrep/der297. Epub 2011 Sep 16.

    PMID: 21926054BACKGROUND

  • Laven JS, Mulders AG, Visser JA, Themmen AP, De Jong FH, Fauser BC. Anti-Mullerian hormone serum concentrations in normoovulatory and anovulatory women of reproductive age. J Clin Endocrinol Metab. 2004 Jan;89(1):318-23. doi: 10.1210/jc.2003-030932.

    PMID: 14715867BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Results Point of Contact

Title
R. Jeffrey Chang
Organization
UCSDMED
rjchang@ucsd.edu
858-534-8930

Study Officials

  • R. Jeffrey Chang, M.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Reproductive Endocrinology. Fellowship Director

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2017

Study Completion

January 1, 2018

Last Updated

August 12, 2019

Results First Posted

August 12, 2019

Record last verified: 2019-08

Locations

US(1)