A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation
NCT ID: NCT02607293
Last Updated: 2018-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1064 participants
OBSERVATIONAL
2015-12-31
2017-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
35 Years
FEMALE
No
Sponsors
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Merck Serono Co., Ltd., China
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Serono Co., Ltd., China
Locations
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Merck KGaA Communication Center
Darmstadt, , Germany
Countries
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Other Identifiers
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700623_547
Identifier Type: -
Identifier Source: org_study_id
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