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

ART assisted reproduction technology; BMI body mass index; FSH follicle-stimulating hormone; OHSS ovarian hyperstimulation syndrome; r-hFSH recombinant human follicle-stimulating hormone