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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: on average 30 days if not pregnant and 12 weeks if pregnant ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: November 2005
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

Ages Eligible for Study:   18 Years to 42 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas D'Hooghe, Profsessor Medical Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01569945     History of Changes
Other Study ID Numbers: ML2436 - 1
Study First Received: March 28, 2012
Last Updated: March 30, 2012
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013