A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

Inclusion criteria

• females of infertile couples for whom COS and IVF or ICSI is indicated
• body mass index between 18 and 29 kg/m2
• willing and able to give written informed consent.

Exclusion criteria

• More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)
• History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment
• Less than 2 ovaries or any other ovarian abnormality including endometrioma
• Presence of unilateral or bilateral hydrosalpinx
• Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
• History of or current polycystic ovary syndrome (PCOS)
• History of/or current endocrine abnormality
• Any clinically relevant hormone value outside the reference range during the early follicular phase
• Any clinically significant abnormal laboratory value
• Hypertension or currently treated hypertension
• Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease
• Alcohol or drug abuse, or history thereof
• Current serious allergic symptoms
• Abnormal cervical smear
• Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;
• Contra-indications for the use of gonadotropins
• Use of hormonal preparations within 1 month prior to the date of signing consent;
• Administration of any investigational product within 3 months prior to screening.