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OpenTrials
Completed

NCT Number: NCT01569945

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

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)?

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leuven University Fertility Center

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomifen, Ethinyl Estradiol

Drug

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

Menotropins

Drug

Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU

Primary outcomes

  1. pregnancy rate

    Time frame: on average 30 days if not pregnant and 12 weeks if pregnant

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2011
First posted
Apr 3, 2012
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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