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

May 5, 2015 updated by: Juan A Garcia-Velasco, IVI Madrid

GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

662

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • IVI-Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women with patent tubes who were undergoing IUI due to infertily of unknown origin.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 2 weeks after intervention
2 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
premature luteinization
Time Frame: at the time of intervention
at the time of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

October 25, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (ESTIMATE)

October 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVIMAD-JMS-09-2008-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Ganirelix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe