LP: Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

Sponsor

IVI Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT00780858

Collaborator

(none)

662

Enrollment

Location

28.9

Duration (Months)

22.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Ganirelix

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

662 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Ganirelix Patients with premature lutenization (progesterone >1,2 ng/ml) who did not get pregnant during the first IUI underwent a second IUI.	Drug: Ganirelix Ganirelix 0.25mg s.c every 24 h starting stimulation day 6 Other Names: Orgalutran
Control Patients without premature lutenization (progesterone >1,2 ng/ml) underwent a only one IUI.

Arm

Intervention/Treatment

Ganirelix

Patients with premature lutenization (progesterone >1,2 ng/ml) who did not get pregnant during the first IUI underwent a second IUI.

Drug: Ganirelix

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

Other Names:

Orgalutran

Control

Patients without premature lutenization (progesterone >1,2 ng/ml) underwent a only one IUI.

Outcome Measures

Primary Outcome Measures

Pregnancy rate [2 weeks after intervention]

Secondary Outcome Measures

premature luteinization [at the time of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	IVI-Madrid	Madrid		Spain	28023

Sponsors and Collaborators

IVI Madrid

Investigators

Principal Investigator: Juan antonio García-Velasco, MD, IVI Madrid

Study Documents (Full-Text)

None provided.

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:

Juan A Garcia-Velasco, MD, IVI Madrid

ClinicalTrials.gov Identifier:

NCT00780858

Other Study ID Numbers:

IVIMAD-JMS-09-2008-02

First Posted:

Oct 28, 2008

Last Update Posted:

May 6, 2015

Last Verified:

May 1, 2015

Keywords provided by Juan A Garcia-Velasco, MD, IVI Madrid

GnRH antagonist

IUI

Additional relevant MeSH terms:

Infertility

Ganirelix

Study Results

No Results Posted as of May 6, 2015