This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid Identifier:
First received: October 25, 2008
Last updated: May 5, 2015
Last verified: May 2015
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
Infertility Drug: Ganirelix

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Resource links provided by NLM:

Further study details as provided by Juan A Garcia-Velasco, IVI Madrid:

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

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

Enrollment: 662
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00780858

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

Responsible Party: Juan A Garcia-Velasco, MD, IVI Madrid Identifier: NCT00780858     History of Changes
Other Study ID Numbers: IVIMAD-JMS-09-2008-02
Study First Received: October 25, 2008
Last Updated: May 5, 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 processed this record on August 18, 2017