An observational study in Polycystic Ovary Syndrome, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Germany. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-06-28.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
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).
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 1,064 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infertile women undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol using Gonal-f® new pen who are expected to be normal or high responders.
Exclusion Criteria:
Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG) as per routine clinical practice. No visits or intervention(s) additional to the routine practice of the Investigators will be performed during this observational study.
Drug: Gonal-f® · Drug: Long GnRH agonist · Drug: GnRH antagonist
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.
Also known as: Recombinant human follicle stimulating hormone
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.
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.
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
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany