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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
185
Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is \>=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day.
Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is \>=14 mm until r-hCG day.
Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day.
Percentage of subjects without premature luteinizing hormone (LH) surge
Time frame: r-hCG administration day (end of stimulation cycle {approximately 4 days})
Duration of study treatment
Time frame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})
Total dose of recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) administered
Time frame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})
Duration of gonadotropin therapy
Time frame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days})
Number of follicles greater than or equal to (>=) 14 millimeter (mm) on day of recombinant human chorionic gonadotropin (r-hCG) administration
Time frame: r-hCG administration day (end of stimulation cycle {approximately 4 days})
Number of oocytes retrieved
Time frame: Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
Number of mature oocytes retrieved
Time frame: OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
Number of fertilized oocytes
Time frame: Day 1 post OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
Number and Quality of Embryos
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Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG).
The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of \>=18 mm and two additional follicles of \>=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG.
Time frame: Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
Implantation rate
Time frame: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days})
Total number of transferred and cryopreserved embryos
Time frame: Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}])
Percentage of subjects with clinical and biochemical pregnancies
Time frame: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days})
Quality of Life assessed by Short Form- 36 (SF-36) Questionnaire
Time frame: Stimulation Day 1 (S1) and Day 15-18 post r-hCG administration (end of stimulation cycle {approximately 4 days})