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NCT00780858 Clinical Trial

Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

Infertility Clinical Trial

— LP  

Official title:
GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00780858
Other study ID # IVIMAD-JMS-09-2008-02
Secondary ID
Status Completed
Phase N/A
First received October 25, 2008
Last updated May 5, 2015
Start date October 2008
Est. completion date March 2011

Study information
Verified date May 2015
Source IVI Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical Trial Summary

Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These patients, according to recent data, have a lower pregnancy rate than controls. The possibility to avoid premature luteinization with GnRH antagonist may restore the chances of achieving a pregnancy in these women.

Description:

The purpose of this study was to investigate whether a subset of patients benefits from GnRHa administration during IUI. PL was tested for in patients who were undergoing artificial insemination procedures, and the effect of GnRHa on PR in patients who

Recruitment information / eligibility
Status Completed
Enrollment 662
Est. completion date March 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- previous failed IUI cycle with premature luteinization

Exclusion Criteria:

- 39 years or older

- not eligible for IUI (patent tubes, > 3 million capacitated spermatozoa)

- 4 previous IUI cycles

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Ganirelix
Ganirelix 0.25mg s.c every 24 h starting stimulation day 6

Locations
Country Name City State
Spain IVI-Madrid Madrid

Sponsors (1)
Lead Sponsor Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Kosmas IP, Tatsioni A, Kolibianakis EM, Verpoest W, Tournaye H, Van der Elst J, Devroey P. Effects and clinical significance of GnRH antagonist administration for IUI timing in FSH superovulated cycles: a meta-analysis. Fertil Steril. 2008 Aug;90(2):367-72. Epub 2007 Oct 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rate 2 weeks after intervention No
Secondary premature luteinization at the time of intervention No
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