EARLY FOLLICULAR PHASE vs LUTHEAL PHASE OVARIAN STIMULATION IN BOLOGNA CRITERIA IVF/ICSI CYCLES: A RANDOMIZED COMPARATIVE SINGLE CENTER TRIAL. LUTEAL TRIAL

INTERVENTION: Trade Name: Pergoveris 150 UI/75 UI polvo y disolvente para solución inyectable Pharmaceutical Form: Solution for injection INN or Proposed INN: FOLLITROPIN ALFA Current Sponsor code: G03GA30 Other descriptive name: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 150‐ INN or Proposed INN: LUTROPIN ALFA CAS Number: 152923‐57‐4 Current Sponsor code: G03GA30 Other descriptive name: LUTROPIN ALFA Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 75‐ CONDITION: Patients with diagnosis of low response (Bologna criteria) and who perform ovarian stimulation for accumulation of vitrified oocytes. ; MedDRA version: 18.1 Level: LLT Classification code 10016398 Term: Female infertility 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 study the efficacy of ovarian stimulation in luteal phase compared to ovarian stimulation in follicular phase in women with low responder criteria. Primary end point(s): Number of oocytes in metaphase II obtained Secondary Objective: ‐Assess whether there are differences between the two groups in terms of duration of stimulation; ‐Study of the differences between the two groups in terms of consumption of gonadotropins and cost of treatment; ‐Assess whether there are differences between the two groups in the rate of cancellation of the stimulation cycle; ‐Assess whether there are differences between the two groups in the rate of oocytes in metaphase II stage; ‐Assess whether there are differences between the two groups in the rate of survival in the thawing and fertilization rate after microinjection. Timepoint(s) of evaluation of this end point: End of controlled ovarian hyperstimulation and oocyte maturation SECONDARY OUTCOME: Secondary end point(s): ‐ Number of oocytes cumulus complexes; ‐ Duration of stimulation (days); ‐ Cycle cancellation rate; ‐ The LH levels following administration of agonist for final oocyte maturation day; ‐ Fertilization rate Timepoint(s) of evaluation of this end point: End of controlled ovarian hyperstimulation and oocyte maturation INCLUSION CRITERIA: . Patient Bologna meets the criteria to be diagnosed as low responder. 2. Age under 41 years 3. Regular menstrual cycles between 21 and 35 days. 4. indication of in vitro fertilization 5. Indication of start stimulation with 300 IU of FSH 6. Presence of both ovaries 7. Ability to participate and comply with the study protocol 8. Having signed 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range