Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve
NCT ID: NCT01389713
Last Updated: 2011-07-12
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
NA
289 participants
INTERVENTIONAL
2008-09-30
2010-12-31
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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High doses
Administration of high doses of gonadotrophins to stimulate ovarian follicular growth
GnRH analog and recombinant human FSH
daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.
Clomid
Administration of Clomiphene Citrate to obtain ovarian follicular growth
Clomifene Citrate
3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
Interventions
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Clomifene Citrate
3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
GnRH analog and recombinant human FSH
daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* infertility status
* Day 3 serum FSH \> 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation
Exclusion Criteria
18 Years
42 Years
FEMALE
No
Sponsors
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Istituto Clinico Humanitas
OTHER
IRCCS San Raffaele
OTHER
Istituti Clinici Zucchi
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigators
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guido ragni, md
Role: PRINCIPAL_INVESTIGATOR
Fondazione Ca' Granda Ospedale Maggiore Policlinico
Locations
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Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Countries
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References
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Heijnen EM, Eijkemans MJ, De Klerk C, Polinder S, Beckers NG, Klinkert ER, Broekmans FJ, Passchier J, Te Velde ER, Macklon NS, Fauser BC. A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial. Lancet. 2007 Mar 3;369(9563):743-749. doi: 10.1016/S0140-6736(07)60360-2.
Eijkemans MJ, Heijnen EM, de Klerk C, Habbema JD, Fauser BC. Comparison of different treatment strategies in IVF with cumulative live birth over a given period of time as the primary end-point: methodological considerations on a randomized controlled non-inferiority trial. Hum Reprod. 2006 Feb;21(2):344-51. doi: 10.1093/humrep/dei332. Epub 2005 Oct 20.
Ragni G, Levi-Setti PE, Fadini R, Brigante C, Scarduelli C, Alagna F, Arfuso V, Mignini-Renzini M, Candiani M, Paffoni A, Somigliana E. Clomiphene citrate versus high doses of gonadotropins for in vitro fertilisation in women with compromised ovarian reserve: a randomised controlled non-inferiority trial. Reprod Biol Endocrinol. 2012 Dec 18;10:114. doi: 10.1186/1477-7827-10-114.
Other Identifiers
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clomid re-007
Identifier Type: -
Identifier Source: org_study_id
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