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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:
ClinicalTrials.gov Identifier:
NCT01569945
First Posted: April 3, 2012
Last Update Posted: September 10, 2014
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
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 Intervention
Subfertility Drug: Clomifen, Ethinyl Estradiol Drug: Menotropins

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

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

Enrollment: 371
Study Start Date: September 2004
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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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
  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): NCT01569945


Locations
Belgium
Leuven University Fertility Center
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Thomas D'Hooghe, MD PhD University Hospital, Gasthuisberg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas D'Hooghe, Profsessor Medical Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01569945     History of Changes
Other Study ID Numbers: ML2436 - 1
First Submitted: March 28, 2012
First Posted: April 3, 2012
Last Update Posted: September 10, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Clomiphene
Enclomiphene
Zuclomiphene
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Estrogen Antagonists
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators