NCT00725491

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Controlled Ovarian Stimulation

Interventions

Type	Name	Description
DRUG	ganirelix	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.
DRUG	triptorelin	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.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-07-30
• Last updated: 2022-02-03
• Results posted: 2010-01-22