Infertility
Conditions
Keywords
IVF, poor responder, recFSH, Fertilization in Vitro, Poor responders
Brief summary
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.
Detailed description
Women \> 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups: 300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration. Patient can be eligible for several cycles in same protocol.
Interventions
DRUGGonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 300 U
Sponsors
EMD Serono
Centre Hospitalier Chretien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Women \> 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol. * Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration. * Patient can be eligible for several cycles in same protocol.
Exclusion criteria
* Patients who already received doses \> 225 IU * Patients older than 42 years * Patients with basal FSH concentrations ≥ 15 mU/ml at day 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of mature oocytes | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| follicular development | 1 month |
| fertilization rate | 1 month |
| implantation rate | 1 month |
| embryo quality | 1 month |
| pregnancy rate | 1 month |
Countries
Belgium
Outcome results
None listed