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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Gonal-f®
* Drug: Long GnRH agonist
* Drug: GnRH antagonist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects undergoing ART treatment with long GnRH-a or GnRH-ant<br>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®<br>* 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.<br>* Other names: Recombinant human follicle stimulating hormone;Drug: Long GnRH agonist<br>* 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.<br>Drug: GnRH antagonist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Metaphase II (M II) oocyte retrieved |  | 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 | 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. | 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. | 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. | 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. | Baseline up to 13 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Gonadotropin releasing hormone agonist (GnRH-a), Gonal-f, Assisted Reproductive Technology