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Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01569945
First received: March 28, 2012
Last updated: March 30, 2012
Last verified: March 2012
History of Changes

March 28, 2012
March 30, 2012
November 2005
December 2010   (final data collection date for primary outcome measure)
pregnancy rate [ Time Frame: on average 30 days if not pregnant and 12 weeks if pregnant ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01569945 on ClinicalTrials.gov Archive Site
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Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
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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)?
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Subfertility
  • Drug: Clomifen, Ethinyl Estradiol
    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
  • Drug: Menotropins
    Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU
  • Active Comparator: Tablets
    Clomifen (5 days) followed by Ethinyl Estradiol (5 days)
    Intervention: Drug: Clomifen, Ethinyl Estradiol
  • Active Comparator: human menopausal gonadotropins
    Daily Injections
    Intervention: Drug: Menotropins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
371
December 2011
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 42 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01569945
ML2436 - 1
No
Thomas D'Hooghe, University Hospital, Gasthuisberg
University Hospital, Gasthuisberg
Not Provided
Principal Investigator: Thomas D'Hooghe, MD PhD University Hospital, Gasthuisberg
University Hospital, Gasthuisberg
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP