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)

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Controlled Ovarian Stimulation

Intervention / Treatment
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* Drug: ganirelix
* Drug: triptorelin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ganirelix | Drug: ganirelix<br>* 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.<br>* Other names: Org 37462;|
| Active Comparator: 2<br>triptorelin | Drug: triptorelin<br>* 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.<br>* Other names: Decapeptyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. | The hCG criterion is met the first day that 3 follicles >= 17 mm are observed. | At completion of ovarian stimulation; maximally after 18 days of recFSH administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reproductive, techniques, assisted