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

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Gonal-f®; Drug: Long GnRH agonist; Drug: GnRH antagonist

• Registration Number: NCT02607293
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Study Start: 2015-12-31
• Primary Completion: 2017-03-16
• Study Completion: 2017-06-28
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1064

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant	Gonal-f®	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.
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant	Long GnRH agonist	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.
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant	GnRH antagonist	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects with polycystic ovary	Baseline
Serum Testosterone levels	Baseline
Number of subjects with history of menstrual disorders	Baseline
Number of subjects with hirsutism	Baseline
Number of oocytes retrieved	Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)

Secondary Outcome Measures

Name	Time	Method
Implantation Rate	4 to 6 Weeks after Embryo transfer (Up to 4 months)	Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)	Baseline up to 1 month
Daily Dose of Recombinant Follicle Stimulating Hormone (r-FSH)	Baseline up to 1 month
Biochemical pregnancy rate	4 to 6 Weeks after Embryo transfer (Up to 4 months)	Biochemical pregnancy was defined as a positive pregnancy test (serum beta-hCG test) of the post-treatment assessment period
Number of Metaphase II (M II) oocyte retrieved	Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)
Clinical pregnancy rate	4 to 6 Weeks after Embryo transfer (Up to 4 months)	Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.
Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)	Baseline up to 13 month	OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)	Baseline up to 13 month	OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, haemoconcentration, and increased blood clotting.

Trial Locations

Locations (1)

Merck KGaA Communication Center; 🇩🇪 Darmstadt, Germany