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
Overview
- Phase
- Not Applicable
- Intervention
- Gonal-f®
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 1064
- Locations
- 1
- Primary Endpoint
- Number of subjects with polycystic ovary
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant
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.
Intervention: Gonal-f®
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant
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.
Intervention: Long GnRH agonist
Subjects undergoing ART treatment with long GnRH-a or GnRH-ant
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.
Intervention: GnRH antagonist
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Implantation Rate(4 to 6 Weeks after Embryo transfer (Up to 4 months))
- 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))
- 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))
- Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)(Baseline up to 13 month)
- Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)(Baseline up to 13 month)