Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
NCT ID: NCT03809429
Last Updated: 2024-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
437 participants
INTERVENTIONAL
2019-04-29
2022-02-16
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
NONE
Study Groups
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FE 999049 + GnRH agonist (GONAPEPTYL)
FE 999049 + GnRH agonist (GONAPEPTYL)
Pre-filled injection pen
FE 999049 + GnRH antagonist (CETROTIDE)
FE 999049 + GnRH antagonist (CETROTIDE)
Powder and solvent for solution for injection
Interventions
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FE 999049 + GnRH agonist (GONAPEPTYL)
Pre-filled injection pen
FE 999049 + GnRH antagonist (CETROTIDE)
Powder and solvent for solution for injection
Eligibility Criteria
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Inclusion Criteria
* The participants must have a regular menstrual cycle, a normal uterus and 2 normal ovaries.
* The allowed body mass index is 17.5-32 Kg/m\^2.
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Das Kinderwunsch Institut Schenk GmbH
Dobl, , Austria
Kepler University Hospital Linz
Linz, , Austria
Kinderwunschzentrum Goldenes Kreuz Privatklinik
Vienna, , Austria
Rigshospitalet
Copenhagen, , Denmark
Hillel Yafe Medical Center
Hadera, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Beilinson Hospital Rabin Medical Center
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Dipartimento della Donna, del bambino e delle malattie urologiche
Bologna, , Italy
European Hospital
Roma, , Italy
St. Elisabeth Ziekenhuis
Tilburg, , Netherlands
Isala Fertility Center
Zwolle, , Netherlands
Oslo University Hospital
Oslo, , Norway
Sykehuset Telemark HF
Porsgrunn, , Norway
Medicus AS
Trondheim, , Norway
Gyn-A.R.T. AG
Zurich, , Switzerland
Countries
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References
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Lobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002783-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000304
Identifier Type: -
Identifier Source: org_study_id
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