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

This study has suspended participant recruitment.

(change in the methodology to measure progesterone in blood, we are still in the process of generating these cutoff levels prior to re-initiate the trial.)

Sponsor:

Information provided by:

Instituto Valenciano de Infertilidad, Spain

ClinicalTrials.gov Identifier:

NCT00780858

First received: October 25, 2008

Last updated: March 16, 2011

Last verified: March 2011

History of Changes

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Resource links provided by NLM:

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Ganirelix Ganirelix acetate

U.S. FDA Resources

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

Locations

Spain
IVI-Madrid
Madrid, Spain, 28023

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:	Javier Martinez-Salazar, IVI-Madrid
ClinicalTrials.gov Identifier:	NCT00780858 History of Changes
Other Study ID Numbers:	IVIMAD-JMS-09-2008-02
Study First Received:	October 25, 2008
Last Updated:	March 16, 2011
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, Spain:

premature luteinization
IUI
GnRH antagonist

Additional relevant MeSH terms:

Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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