Clinical trial NCT00298025: A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation
Official title: A Phase IV, Multicenter, Open-label, Randomized Study to Compare the Safety and Efficacy of Cetrotide® 3 mg Versus Antagon™ in the Inhibition of a Premature LH Surge in a r-hFSH/hMG Stimulation Cycle With OCP Programming in Women Undergoing Ovarian Stimulation Prior to ART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertile Women Undergoing Assisted Reproductive Technology (ART)
Keywords: Infertility
Cetrotide
Antagon
Recombinant human follicle stimulating hormone (r-hFSH)
Human Menopausal Gonadotropin (hMG)
Recombinant Human Choriogonadotropin (r-hCG)
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2006-03-01
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of subjects without premature luteinizing hormone (LH) surge
timeFrame: r-hCG administration day (end of stimulation cycle {approximately 4 days})
Secondary outcomes:
measure: Duration of study treatment
timeFrame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})
measure: Total dose of recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) administered
timeFrame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})
measure: Duration of gonadotropin therapy
timeFrame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})
measure: Number of follicles greater than or equal to (>=) 14 millimeter (mm) on day of recombinant human chorionic gonadotropin (r-hCG) administration
timeFrame: r-hCG administration day (end of stimulation cycle {approximately 4 days})
measure: Number of oocytes retrieved
timeFrame: Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
measure: Number of mature oocytes retrieved
timeFrame: OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
measure: Number of fertilized oocytes
timeFrame: Day 1 post OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
measure: Number and Quality of Embryos
timeFrame: Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
measure: Implantation rate
timeFrame: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days})
measure: Total number of transferred and cryopreserved embryos
timeFrame: Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
measure: Percentage of subjects with clinical and biochemical pregnancies
timeFrame: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days})
measure: Quality of Life assessed by Short Form- 36 (SF-36) Questionnaire
timeFrame: Stimulation Day 1 (S1) and Day 15-18 post r-hCG administration (end of stimulation cycle {approximately 4 days})
Other outcomes:
Locations:
Study officials:
affiliation: EMD Serono
name: Eduardo Kelly, MD, MBA
role: STUDY_DIRECTOR
References:
citation: Wilcox J, Potter D, Moore M, Ferrande L, Kelly E; CAP IV Investigator Group. Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies. Fertil Steril. 2005 Jul;84(1):108-17. doi: 10.1016/j.fertnstert.2005.03.016.