Among non-IVF patients undergoing ovulation induction with clomiphene citrate (Clomid® 50 mg) and having no reaction at day 13 of the cycle, does administration of an increased dose of clomiphene citrate (Clomid® 100 mg) compared with gonadotropins, achieve similar rates of folliculogenesis?
- Conditions
- 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.
- Registration Number
- EUCTR2008-006372-29-BE
- Lead Sponsor
- Blockeel Christophe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 40
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)
Randomisation at monitoring
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
= 39 years old on day of randomisation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.<br>The primary endpoint of the study is the folliculogenesis in each treatment group.;Secondary Objective: The secondary endpoint is the pregnancy rate in each treatment group.;Primary end point(s): Folliculogenesis in each treatment group
- Secondary Outcome Measures
Name Time Method