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

Polycystic Ovary Syndrome Clinical Trial

— ARTIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607293
• Other study ID #: 700623_547
• Status: Completed
• Start date: December 31, 2015
• Est. completion date: June 28, 2017

Study information

• Verified date: June 2018
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1064
• Est. completion date: June 28, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Female subjects aged 20 to 35 years (including both)

• Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG)

• Subject from whom a written informed consent has been obtained with the understanding that the subject may withdraw consent at any time without prejudice to future medical care

Exclusion Criteria:

• Subjects undergoing ART treatment with mild stimulation protocol

• Concomitant use of Gonal-f® with clomiphene citrate

• With an In vitro fertilisation (IVF)/ Intracytoplasmic sperm injection (ICSI) history of greater than or equal to (>=) 3 times

• Known history of poor ovarian response in a previous COS cycle for IVF/ICSI, defined as less than 4 oocytes retrieved or history of previous cycle cancellation prior to oocyte retrieval due to poor response or poor ovarian reserve, such as Antral follicle count (AFC) less than (<) 5 to 7

• Presence of confirmed or suspected endometriosis Grade III - IV

• Presence of unilateral or bilateral hydrosalpinx

• Using other Gn during stimulation period (such as urinary FSH/human menopausal Gn, except for recombinant luteinizing hormone (r-LH))

• Known history of recurrent miscarriage

• Any contradiction to Gn/GnRH analogues

• Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study

• According to the judgment of the Investigator, any medical condition or any concomitant

• surgery/ medications that would interfere with evaluation of study medications

• Simultaneous participation in another clinical study

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Signs and Symptoms
• Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Merck KGaA Communication Center	Darmstadt

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Co., Ltd., China

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with polycystic ovary		Baseline
Primary	Serum Testosterone levels		Baseline
Primary	Number of subjects with history of menstrual disorders		Baseline
Primary	Number of subjects with hirsutism		Baseline
Primary	Number of oocytes retrieved		Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Secondary	Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)		Baseline up to 1 month
Secondary	Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)		Baseline up to 1 month
Secondary	Number of Metaphase II (M II) oocyte retrieved		Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Secondary	Biochemical pregnancy rate	Biochemical pregnancy was defined as a positive pregnancy test (serum beta-hCG test) of the post-treatment assessment period	4 to 6 Weeks after Embryo transfer (Up to 4 months)
Secondary	Clinical pregnancy rate	Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.	4 to 6 Weeks after Embryo transfer (Up to 4 months)
Secondary	Implantation Rate	Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.	4 to 6 Weeks after Embryo transfer (Up to 4 months)
Secondary	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.	Baseline up to 13 month
Secondary	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.	Baseline up to 13 month