Status:
COMPLETED
A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation
Lead Sponsor:
EMD Serono
Conditions:
Infertile Women Undergoing Assisted Reproductive Technology (ART)
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation w...
Eligibility Criteria
Inclusion
- Infertile women wishing to conceive whose physician had recommended that she can undergo ART
- Aged 18-39 years (inclusive)
- Regular menstrual cycles every 25-35 days
- Body mass index (BMI) less than 35 kilogram per square meter (kg/m\^2)
- Has a transvaginal pelvic ultrasound scan within 6 weeks prior to OCP administration, as well as an Hysterosalpingography (HSG) or hysterosonogram or hysteroscopy within three years prior to OCP administration showing no clinically significant pelvic and/or uterine abnormality, which, in the Investigator's opinion, could impair ovarian response, embryo implantation or pregnancy continuation
- Normal cervical cytology, documented by Pap Smear, within six months prior to OCP administration
- If the subject had prior stimulation cycles, at least a 60-day washout period is required after the last dose of gonadotropin or clomiphene citrate; a 60-day washout is required after the last dose of Lupron® or Lupron Depot® 1-month; a 180-day washout period is required after the last dose of treatment with Depo-Provera® and Lupron Depot® 6-month; a 60-day washout is required after the last dose of oral contraceptives prior to OCP administration in the study
- Screening laboratory results for follicle stimulating hormone (FSH) that are within the normal limit for the early follicular phase at the local laboratory
- Is willing and able to comply with the protocol for the duration of the study
- Has voluntarily provided written informed consent and a subject authorization under Health insurance portability and accountability act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care
Exclusion
- Clinically significant systemic disease
- Known to be infected with Human Immunodeficiency Virus (HIV)
- Known to be infected with Hepatitis C virus
- Known to test positive for Hepatitis B surface antigens
- Any medical condition, which, in the judgment of the Investigator and Sponsor, may interfere with the absorption, distribution, metabolism or excretion of the study drugs
- Known endometriosis Grade III-IV (American society of reproductive medicine \[ASRM\] classification)
- Uni- or bilateral hydrosalpinx
- Any contraindication to being pregnant and/or carrying pregnancy to term
- Any previous ART cycle indicating a poor response to gonadotropin stimulation (defined as retrieval of three oocytes or less)
- If, in a previous ART attempt, there are no motile sperm before or after the sperm processing with ejaculated, epididymal, testicular, fresh or frozen/thawed spermatozoa
- Three or more previous consecutive ART cycles without a clinical pregnancy
- An extrauterine pregnancy within the last three months before OCP treatment commences
- Abnormal, undiagnosed, gynecological bleeding
- Known allergy or hypersensitivity to human gonadotropin preparations or any other study-related medications
- Known current substance abuse
- Previous participation in this study or simultaneous participation in another clinical trial
- Current smoker
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00298025
Start Date
September 1 2003
End Date
May 1 2004
Last Update
March 26 2014
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