Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI - Full Text View

Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI (LP)

This study is currently recruiting participants.

Verified by Instituto Valenciano de Infertilidad, Spain, October 2008

Sponsored by:	Instituto Valenciano de Infertilidad, Spain
Information provided by:	Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:	NCT00780858

Purpose

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.

Condition	Intervention
Intrauterine Insemination	Drug: ganirelix Drug: no intervention

Drug Information available for: Gonadorelin Gonadorelin hydrochloride LH-RH Ganirelix Ganirelix acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:

Pregnancy rate [ Time Frame: 2 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

premature luteinization [ Time Frame: at the time of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	416
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
antagonist: Experimental	Drug: ganirelix 0.25mg s.c every 24 h starting stimulation day 6
Control: No Intervention	Drug: no intervention no intervention

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780858

Contacts

Contact: Javier Martinez-Salazar, MD

34911802900

jmartinez@ivi.es

Locations

Spain
IVI-Madrid	Recruiting
Madrid, Spain, 28023
Contact: Javier Martinez-Salazar, MD 349118090 jmartinez@ivi.es
Principal Investigator: Javier Martinez-Salazar, MD

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, Spain

More Information

Publications:

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.

Responsible Party:	IVI-Madrid ( Javier Martinez-Salazar )
Study ID Numbers:	IVIM-2008-11
Study First Received:	October 25, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00780858
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, Spain:

premature luteinization
IUI
GnRH antagonist

Study placed in the following topic categories:

Ganirelix

ClinicalTrials.gov processed this record on January 16, 2009