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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725491
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : January 22, 2010
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

Condition or disease Intervention/treatment Phase
Controlled Ovarian Stimulation Drug: ganirelix Drug: triptorelin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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.
Other Names:
  • Orgalutran®
  • Org 37462
Active Comparator: 2
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.
Other Name: Decapeptyl

Primary Outcome Measures :
  1. 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. [ Time Frame: At completion of ovarian stimulation; maximally after 18 days of recFSH administration. ]
    The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00725491     History of Changes
Other Study ID Numbers: P05703
First Posted: July 30, 2008    Key Record Dates
Results First Posted: January 22, 2010
Last Update Posted: December 3, 2014
Last Verified: November 2014

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists