Table 5 Main Study Inclusion and Exclusion Criteria for Selection of Study Population

Inclusion Criteria

 ▪ Infertile but otherwise healthy women aged 18 to 37 years of any racial origin

 ▪ Normal gonadotropic women with regular menstrual cycles of 21–35 days

 ▪ 2 confirmed normal ovaries and undergoing superovulation for ART

 ▪ BMI ≥18 kg/m² and ≤29 kg/m²

 ▪ Basal FSH, estradiol, prolactin, and thyroid-stimulating hormone concentrations in the normal range

Exclusion Criteria

 ▪ History of more than 2 previously completed consecutive unsuccessful in vitro fertilization cycles; >3 miscarriages; history of a severe OHSS; primary ovarian failure or being categorized as poor responders; hypersensitivity or allergy to r-hFSH preparations; or neoplasm or history of chemotherapy or radiation therapy

 ▪ Malformation of sexual organs incompatible with pregnancy or one or both ovaries inaccessible for oocyte retrieval

 ▪ Administration of clomiphene or gonadotropins within 30 days prior to enrollment

 ▪ Any significant cardiovascular, pulmonary, neurologic, endocrine, hepatic, or renal disease

 ▪ After down-regulation prior to first administration of r-hFSH: serum estradiol ≥50 pg/mL, ovarian cysts >10 mm (verified by ultrasound), or a positive pregnancy test