Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Serono Co., Ltd., China | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonal-f® | Drug | 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. |
| 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) |
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Infertile women undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol using Gonal-f® new pen who are expected to be normal or high responders.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono Co., Ltd., China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck KGaA Communication Center | Darmstadt | Germany |
Not provided
Not provided
Not provided
Not provided
|
|
| Long GnRH agonist | Drug | 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 | Drug | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
Not provided
Not provided
Not provided