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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:
ClinicalTrials.gov Identifier:
NCT00700492
First Posted: June 18, 2008
Last Update Posted: June 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg
  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
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

Resource links provided by NLM:


Further study details as provided by Thomas D'Hooghe, University Hospital, Gasthuisberg:

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

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

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

  Eligibility

Information from the National Library of Medicine

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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 Submitted: June 17, 2008
First Posted: June 18, 2008
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