This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for individualized controlled ovarian stimulation (iCOS).
Study Type
OBSERVATIONAL
Enrollment
1,064
Recombinant human follicle stimulating hormone (r-FSH) will be administered subcutaneously (SC) for about 10 to 20 days along with the ART regimen as routinely practiced by Investigators and according to licensed summary of product characteristics (SmPC label) for the ovarian stimulation.
As a part of the ART regimen GnRH-agonist will be administered for about 14 to 20 days until down regulation is satisfied as judged by investigator.
As a part of ART regimen GnRH-antagonist will be initiated and regimen will be as routinely practiced by Investigators and according to licensed SmPC label.
Merck KGaA Communication Center
Darmstadt, Germany
Number of subjects with polycystic ovary
Time frame: Baseline
Serum Testosterone levels
Time frame: Baseline
Number of subjects with history of menstrual disorders
Time frame: Baseline
Number of subjects with hirsutism
Time frame: Baseline
Number of oocytes retrieved
Time frame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time frame: Baseline up to 1 month
Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time frame: Baseline up to 1 month
Number of Metaphase II (M II) oocyte retrieved
Time frame: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Biochemical pregnancy rate
Biochemical pregnancy was defined as a positive pregnancy test (serum beta-hCG test) of the post-treatment assessment period
Time frame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
Clinical pregnancy rate
Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.
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Time frame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
Implantation Rate
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
Time frame: 4 to 6 Weeks after Embryo transfer (Up to 4 months)
Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.
Time frame: Baseline up to 13 month
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.
Time frame: Baseline up to 13 month