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)

A Phase III, Multi-center, Open-label, Randomized Study to Assess the Efficacy and Safety of Org 37462 Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for IVF or ICSI, Using a Long Protocol of Triptorelin as a Reference Treatment.

The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

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.