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)(COMPLETED)(P05703)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00725491
First received: July 28, 2008
Last updated: February 11, 2010
Last verified: February 2010
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Schering-Plough:
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. ] [ Designated as safety issue: No ]
| Enrollment: | 259 |
| Study Start Date: | April 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ganirelix
|
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:
|
|
Active Comparator: 2
triptorelin
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
No Contacts or Locations Provided
More Information
No publications provided by Schering-Plough
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00725491 History of Changes |
| Other Study ID Numbers: | 38651, P05703 |
| Study First Received: | July 28, 2008 |
| Results First Received: | December 17, 2009 |
| Last Updated: | February 11, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
Reproductive techniques assisted |
Additional relevant MeSH terms:
|
Ganirelix Triptorelin Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Luteolytic Agents |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013