FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

Inclusion Criteria:

• Age: 18-38 years old;
• BMI: 18-28 kg/m2;
• Less than 3 previously completed IVF cycles;
• Basal FSH <10 IU/L and E2 <80 pg/ml;
• TSH < 2.5 mIU/L
• >10 and <30 antral follicles 2-10 mm in size for both ovaries combined
• AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l)
• Presence and adequate visualization of both ovaries;
• Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;

Exclusion Criteria:

• Primary ovarian failure or women known as poor responders;
• PCO and PCOS;
• Severe OHSS in a previous COH cycle;
• Uterine malformation that may impair the possibility to get pregnant;
• Ovarian cysts >10 mm;
• Hydrosalpinx that have not been surgically removed or ligated;
• Endometriosis stage 3 or 4;
• Oocyte donation;
• Severe male factor;
• Pathologies associated with any contraindication of being pregnant;
• History of recurrent miscarriage (more than 3 previous miscarriages);
• Hypersensitivity to the study medication;
• Abnormal bleeding of undetermined origin;
• Uncontrolled thyroid or adrenal dysfunction;
• Neoplasias;
• Severe impairment of renal and/or hepatic function.