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

This study has been terminated.
(Change in Belgian law on the use of hMG in IUI)
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg Identifier:
First received: June 17, 2008
Last updated: June 24, 2015
Last verified: June 2015
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

Condition Intervention
Drug: progesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study

Resource links provided by NLM:

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • clinical pregnancy rate per cycle [ Time Frame: 12 weeks pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of miscarriages per cycle [ Time Frame: 12 weeks pregnancy ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: May 2004
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Experimental: utrogestan
daily use of vaginal progesterone capsules
Drug: progesterone
vaginal capsules 3X200mg daily
Other Name: Utrogestan


Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • ovulation induction with clomiphene citrate
  Contacts and Locations
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Please refer to this study by its identifier: NCT00700492

Leuven University Fertility Center
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Principal Investigator: Thomad D'Hooghe, MD, PhD University Hospital Gasthuisberg, Catholic University Leuven, Belgium
  More Information

No publications provided

Responsible Party: Thomas D'Hooghe, Prof PhD MD, University Hospital, Gasthuisberg Identifier: NCT00700492     History of Changes
Other Study ID Numbers: ML2437-30/12/2003
Study First Received: June 17, 2008
Last Updated: June 24, 2015
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
pregnancy rate

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins processed this record on November 27, 2015