This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: July 28, 2008
Last updated: November 18, 2014
Last verified: November 2014
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 Intervention Phase
Controlled Ovarian Stimulation Drug: ganirelix Drug: triptorelin Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.

Enrollment: 259
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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
Study First Received: July 28, 2008
Results First Received: December 17, 2009
Last Updated: November 18, 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 processed this record on August 23, 2017