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

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ClinicalTrials.gov Identifier: NCT00700492
Recruitment Status : Terminated (Change in Belgian law on the use of hMG in IUI)
First Posted : June 18, 2008
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Subfertility Drug: progesterone

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2004
Primary Completion Date : March 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: control
Experimental: utrogestan
daily use of vaginal progesterone capsules
Drug: progesterone
vaginal capsules 3X200mg daily
Other Name: Utrogestan


Outcome Measures

Primary Outcome Measures :
  1. clinical pregnancy rate per cycle [ Time Frame: 12 weeks pregnancy ]

Secondary Outcome Measures :
  1. rate of miscarriages per cycle [ Time Frame: 12 weeks pregnancy ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thomas D'Hooghe, Prof PhD MD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT00700492     History of Changes
Other Study ID Numbers: ML2437-30/12/2003
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Thomas D'Hooghe, University Hospital, Gasthuisberg:
subfertility
pregnancy rate
miscarriage

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