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NCT01005784 Clinical Trial

Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

Subfertility Clinical Trial

Official title:
Fixed Versus Flexible GnRH Antagonist Initiation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01005784
Other study ID # UHR-3
Secondary ID
Status Completed
Phase Phase 4
First received November 13, 2007
Last updated October 30, 2009
Start date June 2005
Est. completion date March 2008

Study information
Verified date October 2009
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority Greece: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.

Recruitment information / eligibility
Status Completed
Enrollment 146
Est. completion date March 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

- < 39 years of age

- BMI 18.5-29.9

- <= 3 previous IVF cycles

Exclusion Criteria:

- PCOS

- Endometriosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cetrorelix (Cetrotide)
flexible antagonist administration according to specified criteria
• Cetrorelix (Cetrotide)
fixed antagonist administration on day 6 of ovarian stimulation

Locations
Country Name City State
Greece Unit for Human Reproduction Thessaloniki

Sponsors (1)
Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Luteinizing hormone rise 3-14 days (duration of ovarian stimulation) No
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