Status:
COMPLETED
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)
Lead Sponsor:
Organon and Co
Conditions:
Controlled Ovarian Stimulation
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief 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 stimul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT00725491
Start Date
May 1 2007
End Date
December 1 2008
Last Update
February 3 2022
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