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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)
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00700492
First received: June 17, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
Subfertility
 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:

U.S. FDA Resources

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 Drug: progesterone
vaginal capsules 3X200mg daily
Other Name: Utrogestan
Experimental: utrogestan
daily use of vaginal progesterone capsules
 Drug: progesterone
vaginal capsules 3X200mg daily
Other Name: Utrogestan

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided

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

Keywords provided by University Hospital, Gasthuisberg:
subfertility
pregnancy rate
miscarriage

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Progesterone
Fertility Agents, Female
Fertility Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013