Prospective, randomized trial to evaluate the administration of 2 different doses of recombinant FSH to patients with age depended insufficient ovarian response during IVF/ICSI
- Conditions
- Patients with age dependend insufficient ovarian response during IVF/ICSI
- Registration Number
- EUCTR2007-006443-50-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
- Women > 38 years, who had insufficient response to stimulation with regular (for that age) posology of 225 IU of gonadotrophins (urinary or recombinant), in a short agonist protocol in a previous cycle
Insufficient response is defined as: development of < or = 4 mature follicles (of > or = 16 mm) at time of hCG administration.
- Patient can be eligible for several cycles in the same protocol
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
- Patients who received already doses > 225 IU, whatever the outcome was
- Patients older than 43 years
- Patients with basal FSH concentrations > or = 15 mU/ml at Day 3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the usefulness of exceeding the usual daily doses of 225 IU administered to women above 38 years, more in particular to compare the standard maximal dose of 300 IU Gonal-F per day with a higher dose of 450 IU per day.<br>;Secondary Objective: ;Primary end point(s): - Implantation rate per embryo transfer<br>- Pregnancy rate (clinical pregnancy)<br>- Life births<br>- Number of oocytes retrieved<br>- Number of mature oocytes (metaphase II oocytes)<br>- Fertilization rate<br>- Embryo quality<br>
- Secondary Outcome Measures
Name Time Method