A phase III, multicenter, randomized, open, comparative study to evaluate if the addition of r-hLH (Luveris) ti FSH from day 8 of ovarian stimulation is able to decrease total FSH dose and to improve cycle outcome in infertile women undergoing ART, who required high FSH dose in a previous cycle.
- Conditions
- Reduction of the FSH dose needed to obtain/retrieve each oocyte after administration of Luveris to FSH at day 8 of ovarian stimulation.MedDRA version: 6.1Level: PTClassification code 10021928
- Registration Number
- EUCTR2004-002218-13-IT
- Lead Sponsor
- INDUSTRIA FARMACEUTICA SERONO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 250
Inclusion Criteria
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method