A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
NCT ID: NCT02449889
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2016-04-30
2018-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HP-hCG IM
highly purified human chorionic gonadotropin, intramuscularly (IM)
highly purified human chorionic gonadotropin
HP-hCG SC
highly purified human chorionic gonadotropin, subcutaneously (SC)
highly purified human chorionic gonadotropin
rhCG
recombinant human chorionic gonadotropin
recombinant human chorionic gonadotropin
Interventions
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highly purified human chorionic gonadotropin
recombinant human chorionic gonadotropin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented history of infertility
* Body mass index (BMI) between 17.5 and 32.0 kg/m2
* Regular menstrual cycles
Exclusion Criteria
* Known polycystic ovarian syndrome (PCOS)
* History of recurrent miscarriage
* History of more than three previous controlled ovarian stimulation cycles
18 Years
39 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
São Paulo, , Brazil
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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000191
Identifier Type: -
Identifier Source: org_study_id
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