Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles (cc versus FSH)

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: clomiphene citrate; Drug: gonadotropins

Study type: Interventional

Funder types: Other

Identifiers

NCT00835744

2008/192

Details and patient eligibility

About

The purpose of the present study is to analyse prospectively if highly purified hMG compared with increased dose of clomiphene citrate has different outcomes in folliculogenesis in ovulation induction cycles.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• < 39 years old on day of randomisation
• FSH < 12 (in the early follicular phase)
• Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
• Chronic oligo or anovulation (WHO 2)
• BMI between 18 and 31 (both inclusive)

Exclusion criteria

• ≥ 39 years old on day of randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, an increased dose of 100 mg of clomiphene citrate is administered from day 13 until day 17 of the cycle.

Treatment:

Drug: clomiphene citrate

B

Active Comparator group

Description:

Patients undergo a standard treatment with clomiphene citrate from day 3 until day 7 of the cycle at a dose of 50 mg daily. If no reaction on day 13 of the cycle, gonadotropins (75IU) are administered from day 13 until day 17 of the cycle.

Treatment:

Drug: gonadotropins