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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780858
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid

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
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 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 : October 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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 Name: Orgalutran
Patients without premature lutenization (progesterone >1,2 ng/ml) underwent a only one IUI.

Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 2 weeks after intervention ]

Secondary Outcome Measures :
  1. premature luteinization [ Time Frame: at the time of intervention ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy women with patent tubes who were undergoing IUI due to infertily of unknown origin.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780858

Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
Principal Investigator: Juan antonio García-Velasco, MD IVI Madrid

Responsible Party: Juan A Garcia-Velasco, MD, IVI Madrid Identifier: NCT00780858     History of Changes
Other Study ID Numbers: IVIMAD-JMS-09-2008-02
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by Juan A Garcia-Velasco, IVI Madrid:
GnRH antagonist

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs