Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00646568
First received: March 17, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

In an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability. The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.

Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of theca cells for estimating the ovarian reserve, and by that to calculate better the chance for IVF cycle success


Condition Intervention
Infertility
Drug: s.c. human chorionic gonadotropin (Pregnyl)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • androgens levels after stimulation in relation to the ovarian reserve [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: s.c. human chorionic gonadotropin (Pregnyl)
    S.C. Pregnyl 10000 IU once
Detailed Description:

20 women >40 years old and 20 women <35 years old, attended to our IVF unit were included in the study. Another 20 other young women (<35 years) with poor response in previous IVF cycles will be participate. All participants received a single hCG 10000 IU injection on cycle day 2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women on IVF cycle

Exclusion Criteria:

  • Any allergy to injection of human chorionic gonadotropin before
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00646568

Locations
Israel
Hadassah Medical center
Jerusalem, Israel, 12000
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Arik Tzukert, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00646568     History of Changes
Other Study ID Numbers: hcgstimtest-HMO-CTIL
Study First Received: March 17, 2008
Last Updated: June 22, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
IVF
ovarian reserve
androgens
thecal cells
Fertility Agents, Female

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Chorionic Gonadotropin
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014