This is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day).
Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).
Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Ovulation rate
Time frame: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 15 millimeter (mm)
Time frame: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Number of follicles with diameter greater than or equal to (>=) 11 millimeter (mm)
Time frame: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 11 millimeter (mm)
Time frame: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Percentage of participants with mono-follicular ovulation
Time frame: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Number of participants with biochemical pregnancy
Time frame: Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Serum estradiol (E2) levels
Time frame: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Serum androstenedione levels
Time frame: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Serum total renin levels
Time frame: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Serum vascular endothelial growth factor (VEGF) levels
Time frame: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Endometrial thickness
Time frame: Day 0, 1, 2, 3, 4 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Number of participants with clinical pregnancy
Time frame: Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Serum progesterone (P4) levels
Time frame: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
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