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)

Organon

Status and phase

Completed

Phase 3

Conditions

Controlled Ovarian Stimulation

Treatments

Drug: ganirelix

Drug: triptorelin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00725491

38651

P05703

Details and patient eligibility

About

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).

Enrollment

259 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.