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

This study has suspended participant recruitment.
(change in the methodology to measure progesterone in blood, we are still in the process of generating these cutoff levels prior to re-initiate the trial.)
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00780858
First received: October 25, 2008
Last updated: March 16, 2011
Last verified: March 2011
  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
Intrauterine Insemination
Drug: ganirelix
Drug: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GnRH Antagonist Prevention of Premature Luteinization in Patients Undergoing IUI

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

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 ]

Estimated Enrollment: 416
Study Start Date: October 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antagonist Drug: ganirelix
0.25mg s.c every 24 h starting stimulation day 6
No Intervention: Control Drug: no intervention
no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

Publications:
Responsible Party: Javier Martinez-Salazar, 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: March 16, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
premature luteinization
IUI
GnRH antagonist

ClinicalTrials.gov processed this record on September 30, 2014