Does Hormonal Luteal Support After Intra-Uterine Insemination (IUI) Increase the Pregnancy Rate?

Verified by: University Hospital, Gasthuisberg, June 2008
First Received: June 17, 2008 | Last Updated: June 17, 2008 | Phase: N/A | Start Date: May 2004
Overall Status: Terminated | Estimated Enrollment: 82
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A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy...

Brief Summary

Official Title: “Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study”

A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: progesterone
    • vaginal capsules 3X200mg daily

Arms, Groups and Cohorts in this Clinical Trial

  • No Intervention: control
  • Experimental: utrogestan
    • daily use of vaginal progesterone capsules

Outcome Measures for this Clinical Trial

Primary Measures

  • clinical pregnancy rate per cycle
    • Time Frame: 12 weeks pregnancy
      Safety Issue?: No

Secondary Measures

  • rate of miscarriages per cycle
    • Time Frame: 12 weeks pregnancy
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Signed informed consent
  • Tubal patency demonstrated
  • ovulation induction with human menopausal gonadotropin

Exclusion Criteria:

  • ovulation induction with clomiphene citrate

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 43 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: University Hospital, Gasthuisberg Other

Overall Clinical Trial Officials and Contacts

Thomad D'Hooghe, MD, PhD Principal Investigator University Hospital Gasthuisberg, Catholic University Leuven, Belgium  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700492

Study ID Number: ML2437-30/12/2003

ClinicalTrials.gov Identifier: NCT00700492

Health Authority: Belgium: Institutional Review Board

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