Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

NCT ID: NCT00780858

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ganirelix

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

Ganirelix

Intervention Type DRUG

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

Control

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

No interventions assigned to this group

Interventions

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Ganirelix

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

Intervention Type DRUG

Other Intervention Names

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Orgalutran

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Juan A Garcia-Velasco

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan antonio GarcĂ­a-Velasco, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Locations

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IVI-Madrid

Madrid, , Spain

Site Status

Countries

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Spain

References

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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. doi: 10.1016/j.fertnstert.2007.06.064. Epub 2007 Oct 23.

Reference Type BACKGROUND
PMID: 17936285 (View on PubMed)

Other Identifiers

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IVIMAD-JMS-09-2008-02

Identifier Type: -

Identifier Source: org_study_id

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