A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788)

Exclusion Criteria

• •History of or any current (treated) endocrine abnormality;
• •History of ovarian hyper-response1 or history of ovarian hyperstimulation
• •syndrome (OHSS);
• •History of or current polycystic ovary syndrome (PCOS);
• •A basal antral follicle count \> 20 (size \< 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
• •Less than 2 ovaries or any other ovarian abnormality;
• •Presence of unilateral or bilateral hydrosalpinx (visible on USS);
• •Presence of unilateral or bilateral endometriomas (\>10 mm; visible on USS);
• •More than three unsuccessful COS cycles since the last established ongoing
• •pregnancy (if applicable);
• •History of non- or low ovarian response to FSH/hMG treatment;
• •FSH or LH \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
• •Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
• •Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
• •Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
• •History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
• •Previous use of Org 36286;
• •Use of hormonal preparations within 1 month prior to screening;
• •Administration of investigational drugs within three months prior to signing
• •informed consent.