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: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

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

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

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

Lead Sponsor: University Hospital, Gasthuisberg

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 10, 2008

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