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

INTERVENTION: Trade Name: Gonal‐f Product Name: Gonal‐f Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: follitropine alfa CAS Number: 9002‐68‐0 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 75‐ Trade Name: Gonal‐f Product Name: Gonal‐f Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: follitropine alfa CAS Number: 9002‐68‐0 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 75‐ CONDITION: Patients with age dependend insufficient ovarian response during IVF/ICSI PRIMARY OUTCOME: 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.; Primary end point(s): ‐ Implantation rate per embryo transfer; ‐ Pregnancy rate (clinical pregnancy); ‐ Life births; ‐ Number of oocytes retrieved; ‐ Number of mature oocytes (metaphase II oocytes); ‐ Fertilization rate; ‐ Embryo quality; Secondary Objective: INCLUSION CRITERIA: ‐ 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