Back to resultsHormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
Primary Purpose
Subfertility
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Clomifen, Ethinyl Estradiol
Menotropins
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility
Eligibility Criteria
Inclusion Criteria:
- women younger than 42 years old
- infertility of at least one year
- normal tubal, pelvic and uterine anatomy
- semen with total motility count of at least 5 million (at least one sample)
Exclusion Criteria:
- premature ovarian failure
- medical history of tubal or ovarian surgery
- tubal or pelvic adhesions
Sites / Locations
- Leuven University Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tablets
human menopausal gonadotropins
Arm Description
Clomifen (5 days) followed by Ethinyl Estradiol (5 days)
Daily Injections
Outcomes
Primary Outcome Measures
pregnancy rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01569945
First Posted
March 28, 2012
Last Updated
September 9, 2014
Sponsor
University Hospital, Gasthuisberg
1. Study Identification
Unique Protocol Identification Number
NCT01569945
Brief Title
Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (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
What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tablets
Arm Type
Active Comparator
Arm Description
Clomifen (5 days) followed by Ethinyl Estradiol (5 days)
Arm Title
human menopausal gonadotropins
Arm Type
Active Comparator
Arm Description
Daily Injections
Intervention Type
Drug
Intervention Name(s)
Clomifen, Ethinyl Estradiol
Intervention Description
starting on day 2 or 3 of the cycle: 1 tablet of Clomifen each day, for 5 days in a row. Dose 50mg or in subsequent cycles, 25 mg or 100 mg or 150 mg. After the 5 days of Clomifen, one tablet of Ethinyl Estradiol 50 mg per day, for 5 days in a row or until beta hCG is injected
Intervention Type
Drug
Intervention Name(s)
Menotropins
Intervention Description
Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU
Primary Outcome Measure Information:
Title
pregnancy rate
Time Frame
on average 30 days if not pregnant and 12 weeks if pregnant
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women younger than 42 years old
infertility of at least one year
normal tubal, pelvic and uterine anatomy
semen with total motility count of at least 5 million (at least one sample)
Exclusion Criteria:
premature ovarian failure
medical history of tubal or ovarian surgery
tubal or pelvic adhesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D'Hooghe, MD PhD
Organizational Affiliation
University Hospital, Gasthuisberg
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
Citations:
PubMed Identifier
25788569
Citation
Peeraer K, Debrock S, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Mol BW, Spiessens C, De Neubourg D, D'Hooghe TM. Low-dose human menopausal gonadotrophin versus clomiphene citrate in subfertile couples treated with intrauterine insemination: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1079-88. doi: 10.1093/humrep/dev062. Epub 2015 Mar 18.
Results Reference
derived
Learn more about this trial
Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
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