Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism

INTERVENTION: Trade Name: Fostipur 75 UI, polvo y disolvente para solución inyectable Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: FOLLICLE‐STIMULATING HORMONE CAS Number: 9002‐68‐0 Other descriptive name: FOLLICLE‐STIMULATING HORMONE Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 75‐ Trade Name: Bemfola 225 UI/0,375 ml solución inyectable en pluma precargada Pharmaceutical Form: Solution for injection in pre‐filled pen INN or Proposed INN: Follitropin alfa Current Sponsor code: G03GA05 Other descriptive name: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 225‐ Trade Name: Fostipur 150 UI, polvo y disolvente para solución inyectable Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: FOLLICLE‐STIMULATING HORMONE CAS Number: 9002‐68‐0 Other descriptive name: FOLLICLE‐STIMULATING HORMONE Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 150‐ CONDITION: Ovarian stimulation for oocyte donation. ; MedDRA version: 18.1 Level: LLT Classification code 10021940 Term: Infertility, female, of unspecified origin System Organ Class: 100000004872 Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To assess whether the effective use of urinary or recombinant FSH can be influenced by genotype of receptor N680S FSH Gene Polymorphism Primary end point(s): Number of cumulus‐oocyte complexes obtained Secondary Objective: Study the differences in stimulation intensity using recombinant and urinary FSH.; Study treatment cost by genotype FSH receptor and gonadotropin used (urinary versus recombinant); Study cost by oocyte obtained by genotype FSH receptor and gonadotropin used (urinary versus recombinant) Timepoint(s) of evaluation of this end point: At the end of ovarian stimulation, post‐puncture SECONDARY OUTCOME: Secondary end point(s): Number of metaphase II (MII) oocytes; Number of useful oocytes (inseminated or microinjected); Duration of stimulation (days); FSH units obtained by oocyte; FSH cost by oocyte obtained; Fertilization rate Timepoint(s) of evaluation of this end point: All (except the fertilization rate) at the end of ovarian stimulation, post‐puncture; Fertilization rate at 18 hours post‐insemination INCLUSION CRITERIA: Be considered apt to get into the oocyte donation program of Instituto Bernabeu Age between 18 and 30 years Body Mass Index over 18 and under 28 Antral follicle count greater than 9 and less than 25 (adding both ovaries) Patients starting ovarian stimulation with 225 IU of FSH Presence of both ovaries Ability to participate and comply with the study protocol Signing the written consent form 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 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range