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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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ClinicalTrials.gov Identifier: NCT01569945
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg

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)?

Condition or disease Intervention/treatment Phase
Subfertility Drug: Clomifen, Ethinyl Estradiol Drug: Menotropins Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Active Comparator: Tablets
Clomifen (5 days) followed by Ethinyl Estradiol (5 days)
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

Active Comparator: human menopausal gonadotropins
Daily Injections
Drug: Menotropins
Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU




Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: on average 30 days if not pregnant and 12 weeks if pregnant ]


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT01569945


Locations
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Belgium
Leuven University Fertility Center
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
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Principal Investigator: Thomas D'Hooghe, MD PhD University Hospital, Gasthuisberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas D'Hooghe, Profsessor Medical Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01569945    
Other Study ID Numbers: ML2436 - 1
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Infertility
Clomiphene
Menotropins
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Estrogen Antagonists
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators