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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646568
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : June 23, 2011
Information provided by:
Hadassah Medical Organization

Brief Summary:

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 or disease Intervention/treatment Phase
Infertility Drug: s.c. human chorionic gonadotropin (Pregnyl) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: s.c. human chorionic gonadotropin (Pregnyl)
    S.C. Pregnyl 10000 IU once

Primary Outcome Measures :
  1. androgens levels after stimulation in relation to the ovarian reserve [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All women on IVF cycle

Exclusion Criteria:

  • Any allergy to injection of human chorionic gonadotropin before

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646568

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

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Responsible Party: Arik Tzukert, Hadassah Medical Center Identifier: NCT00646568     History of Changes
Other Study ID Numbers: hcgstimtest-HMO-CTIL
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by Hadassah Medical Organization:
ovarian reserve
thecal cells
Fertility Agents, Female
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs