Back to resultsDoes Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?
Primary Purpose
Subfertility
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility focused on measuring subfertility, pregnancy rate, miscarriage
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Tubal patency demonstrated
- ovulation induction with human menopausal gonadotropin
Exclusion Criteria:
- ovulation induction with clomiphene citrate
Sites / Locations
- Leuven University Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
utrogestan
Arm Description
daily use of vaginal progesterone capsules
Outcomes
Primary Outcome Measures
clinical pregnancy rate per cycle
Secondary Outcome Measures
rate of miscarriages per cycle
Full Information
NCT ID
NCT00700492
First Posted
June 17, 2008
Last Updated
June 24, 2015
Sponsor
University Hospital, Gasthuisberg
1. Study Identification
Unique Protocol Identification Number
NCT00700492
Brief Title
Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?
Official Title
Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Change in Belgian law on the use of hMG in IUI
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gasthuisberg
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
subfertility, pregnancy rate, miscarriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Title
utrogestan
Arm Type
Experimental
Arm Description
daily use of vaginal progesterone capsules
Intervention Type
Drug
Intervention Name(s)
progesterone
Other Intervention Name(s)
Utrogestan
Intervention Description
vaginal capsules 3X200mg daily
Primary Outcome Measure Information:
Title
clinical pregnancy rate per cycle
Time Frame
12 weeks pregnancy
Secondary Outcome Measure Information:
Title
rate of miscarriages per cycle
Time Frame
12 weeks pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Tubal patency demonstrated
ovulation induction with human menopausal gonadotropin
Exclusion Criteria:
ovulation induction with clomiphene citrate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomad D'Hooghe, MD, PhD
Organizational Affiliation
University Hospital Gasthuisberg, Catholic University Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leuven University Fertility Center
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?
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