Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2022-11-17
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa
150 micrograms per dose
Control group
Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).
Follitropin Alfa
Variable dose.
Follitropin Alfa Biosimilar
Variable dose.
Urinary Human follicle stimulating hormone
Variable dose.
Interventions
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Corifollitropin Alfa
150 micrograms per dose
Follitropin Alfa
Variable dose.
Follitropin Alfa Biosimilar
Variable dose.
Urinary Human follicle stimulating hormone
Variable dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process.
* Ability to participate and comply with the study protocol.
* To have given written consent
Exclusion Criteria
* Concurrent participation in another study.
18 Years
43 Years
FEMALE
Yes
Sponsors
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Instituto Bernabeu
OTHER
Responsible Party
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Juan Carlos Castillo
Principal investigator
Principal Investigators
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Juan Carlos Castillo Farfan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Bernabeu
Locations
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Instituto Bernabeu
Alicante, , Spain
Countries
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References
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Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.
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.
Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.
Kuang Y, Hong Q, Chen Q, Lyu Q, Ai A, Fu Y, Shoham Z. Luteal-phase ovarian stimulation is feasible for producing competent oocytes in women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment, with optimal pregnancy outcomes in frozen-thawed embryo transfer cycles. Fertil Steril. 2014 Jan;101(1):105-11. doi: 10.1016/j.fertnstert.2013.09.007. Epub 2013 Oct 23.
Vaiarelli A, Cimadomo D, Petriglia C, Conforti A, Alviggi C, Ubaldi N, Ledda S, Ferrero S, Rienzi L, Ubaldi FM. DuoStim - a reproducible strategy to obtain more oocytes and competent embryos in a short time-frame aimed at fertility preservation and IVF purposes. A systematic review. Ups J Med Sci. 2020 May;125(2):121-130. doi: 10.1080/03009734.2020.1734694. Epub 2020 Apr 25.
Vaiarelli A, Cimadomo D, Trabucco E, Vallefuoco R, Buffo L, Dusi L, Fiorini F, Barnocchi N, Bulletti FM, Rienzi L, Ubaldi FM. Double Stimulation in the Same Ovarian Cycle (DuoStim) to Maximize the Number of Oocytes Retrieved From Poor Prognosis Patients: A Multicenter Experience and SWOT Analysis. Front Endocrinol (Lausanne). 2018 Jun 14;9:317. doi: 10.3389/fendo.2018.00317. eCollection 2018.
Castillo JC, Fuentes A, Ortiz JA, Abellan E, Bernabeu A, Bernabeu R. Continuous ovarian stimulation: a proof-of-concept study exploring the uninterrupted use of corifollitropin alpha in DuoStim cycles for enhanced efficiency and patient convenience (Alicante protocol). F S Rep. 2024 Mar 28;5(2):176-182. doi: 10.1016/j.xfre.2024.03.005. eCollection 2024 Jun.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022-003177-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IBMR31
Identifier Type: -
Identifier Source: org_study_id
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