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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid
ClinicalTrials.gov Identifier:
NCT00780858
First received: October 25, 2008
Last updated: May 5, 2015
Last verified: May 2015
  Purpose
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 IVI Madrid:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 2 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • premature luteinization [ Time Frame: at the time of intervention ] [ Designated as safety issue: No ]

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
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 Name: Orgalutran
Control
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
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders 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.
Criteria

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 ClinicalTrials.gov identifier: NCT00780858

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

Publications:
Responsible Party: Juan A Garcia-Velasco, MD, IVI Madrid
ClinicalTrials.gov 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
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by IVI Madrid:
GnRH antagonist
IUI

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

ClinicalTrials.gov processed this record on August 25, 2016