Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
s.c. human chorionic gonadotropin (Pregnyl)
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring IVF, ovarian reserve, androgens, thecal cells, Fertility Agents, Female
Eligibility Criteria
Inclusion Criteria:
- All women on IVF cycle
Exclusion Criteria:
- Any allergy to injection of human chorionic gonadotropin before
Sites / Locations
- Hadassah Medical center
Outcomes
Primary Outcome Measures
androgens levels after stimulation in relation to the ovarian reserve
Secondary Outcome Measures
Full Information
NCT ID
NCT00646568
First Posted
March 17, 2008
Last Updated
June 22, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00646568
Brief Title
Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
Official Title
hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, ovarian reserve, androgens, thecal cells, Fertility Agents, Female
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
s.c. human chorionic gonadotropin (Pregnyl)
Intervention Description
S.C. Pregnyl 10000 IU once
Primary Outcome Measure Information:
Title
androgens levels after stimulation in relation to the ovarian reserve
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All women on IVF cycle
Exclusion Criteria:
Any allergy to injection of human chorionic gonadotropin before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assaf Ben-Meir, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical center
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
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