Corifollitropin Alfa Versus Follitropin Beta in High Responders
NCT ID: NCT02471677
Last Updated: 2015-06-22
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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UNKNOWN
PHASE4
62 participants
INTERVENTIONAL
2015-09-30
2016-12-31
Brief Summary
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Detailed Description
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The purpose of this RCT is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, as well as hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for IVF using a GnRH antagonist protocol. In addition, incidence of unexpected ovarian hyperstimulation syndrome (OHSS) will be evaluated, although it is anticipated that GnRH agonist triggering will eliminate occurrence of the syndrome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Puregon
Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles
Puregon
follitropin beta (Puregon): daily injections 150 IU from Day 2/3 of menstrual cycle until adequate follicle development is achieved
Elonva
Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva)
Elonva
corifollitropin alfa (Elonva): a single injection 100 or 150 ug (depending on patient body weight) on Day 2/3 of menstrual cycle
Interventions
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Elonva
corifollitropin alfa (Elonva): a single injection 100 or 150 ug (depending on patient body weight) on Day 2/3 of menstrual cycle
Puregon
follitropin beta (Puregon): daily injections 150 IU from Day 2/3 of menstrual cycle until adequate follicle development is achieved
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Polycystic ovaries (PCO) or polycystic ovary syndrome (PCOS)
* no endometriotic cyst
Exclusion Criteria
* Patients using human chorionic gonadotropin (hCG) for triggering final oocyte maturation.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Eugonia
OTHER
Responsible Party
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Principal Investigators
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Trifon G Lainas, PhD
Role: STUDY_DIRECTOR
Eugonia
Locations
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Eugonia Unit of Assisted Reproduction
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14.
Fauser BC, Alper MM, Ledger W, Schoolcraft WB, Zandvliet A, Mannaerts BM; Engage Investigators. Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF. Reprod Biomed Online. 2010 Nov;21(5):593-601. doi: 10.1016/j.rbmo.2010.06.032. Epub 2010 Jun 30.
Fauser BC, Mannaerts BM, Devroey P, Leader A, Boime I, Baird DT. Advances in recombinant DNA technology: corifollitropin alfa, a hybrid molecule with sustained follicle-stimulating activity and reduced injection frequency. Hum Reprod Update. 2009 May-Jun;15(3):309-21. doi: 10.1093/humupd/dmn065. Epub 2009 Jan 30.
Other Identifiers
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elonva_hyper-responders
Identifier Type: -
Identifier Source: org_study_id
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