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)
Condition: Controlled Ovarian Stimulation
Intervention: ganirelix; triptorelin
Intervention description: On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.; a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 <= 50 pg/ml (<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.
Intervention MeSH terms: Triptorelin Pamoate; Ganirelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 259.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Reproductive; techniques; assisted

Summary:

      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).
    

Eligibility criteria:

        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.