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

Subfertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569945
• Other study ID #: ML2436 - 1
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: September 9, 2014
• Start date: September 2004
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Subfertility

Intervention

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

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate		on average 30 days if not pregnant and 12 weeks if pregnant	No