NCT02607293

A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation

An Exploratory Study to Explore the Correlation Between the Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response Using New Gonal-f® Pen in Assisted Reproductive Technology (ART) Treatment in China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,064 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Gonal-f®	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.
DRUG	Long GnRH agonist	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.
DRUG	GnRH antagonist	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.

Timeline

• Start date: 2015-12-31
• Primary completion: 2017-03-16
• Completion: 2017-06-28
• First posted: 2015-11-18
• Last updated: 2018-06-28

Locations

1 site across 1 country: Germany