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

University Hospital, Gasthuisberg

Status: Completed

Conditions: Subfertility

Treatments: Drug: Clomifen, Ethinyl Estradiol; Drug: Menotropins

Study type: Interventional

Funder types: Other

Identifiers

NCT01569945

ML2436 - 1

Details and patient eligibility

About

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)?

Enrollment: 371 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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371 participants in 2 patient groups

Tablets

Active Comparator group

Description:

Clomifen (5 days) followed by Ethinyl Estradiol (5 days)

Treatment:

Drug: Clomifen, Ethinyl Estradiol

human menopausal gonadotropins

Active Comparator group

Description:

Daily Injections

Treatment:

Drug: Menotropins