FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
NCT ID: NCT01969201
Last Updated: 2019-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
710 participants
INTERVENTIONAL
2014-01-31
2017-08-31
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
SINGLE
Study Groups
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Fostimon®
75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
Urofollitrophin
Gonal-F®
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Follitrophin alpha
Interventions
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Urofollitrophin
Follitrophin alpha
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI: 18-28 kg/m2;
* Less than 3 previously completed IVF cycles;
* Basal FSH \<10 IU/L and E2 \<80 pg/ml;
* TSH \< 2.5 mIU/L
* \>10 and \<30 antral follicles 2-10 mm in size for both ovaries combined
* AMH: \>1 ng/ml (7.15 pmol/l) and \<5.6 ng/ml (40.0 pmol/l)
* Presence and adequate visualization of both ovaries;
* Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;
Exclusion Criteria
* PCO and PCOS;
* Severe OHSS in a previous COH cycle;
* Uterine malformation that may impair the possibility to get pregnant;
* Ovarian cysts \>10 mm;
* Hydrosalpinx that have not been surgically removed or ligated;
* Endometriosis stage 3 or 4;
* Oocyte donation;
* Severe male factor;
* Pathologies associated with any contraindication of being pregnant;
* History of recurrent miscarriage (more than 3 previous miscarriages);
* Hypersensitivity to the study medication;
* Abnormal bleeding of undetermined origin;
* Uncontrolled thyroid or adrenal dysfunction;
* Neoplasias;
* Severe impairment of renal and/or hepatic function.
18 Years
38 Years
FEMALE
No
Sponsors
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IBSA Institut Biochimique SA
INDUSTRY
Responsible Party
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Principal Investigators
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Pedro Barri, MD
Role: STUDY_CHAIR
Institut Universitari Dexeus, Barcelona, Spain
Christophe Blockeel, MD
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel, Belgium
Locations
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UCL- Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Spedali Civili di Brescia
Brescia, , Italy
Fondazione Ca'Granda, Osp Maggiore Policlinico
Milan, , Italy
IRCCS San Raffaele
Milan, , Italy
Università degli Studi di Napoli 'Federico II'
Naples, , Italy
Azienda Ospedaliera Di Reggio Emilia
Reggio Emilia, , Italy
Clinica IVI Alicante
Alicante, , Spain
Institut Universitari Dexeus
Barcelona, , Spain
Ginefiv Clínica de Fertilidad
Madrid, , Spain
Instituto Valenciano de Infertilidad (IVI)
Seville, , Spain
Universitäts-Frauenklinik
Basel, Canton of Basel-City, Switzerland
Universitätsklinik für Frauenheilkunde
Bern, Canton of Bern, Switzerland
Prof. Bülent Urman
Istanbul, , Turkey (Türkiye)
Ege University
Izmir, , Turkey (Türkiye)
Midland Fertility Services
Aldridge, , United Kingdom
Countries
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Other Identifiers
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13EU/FSH01
Identifier Type: -
Identifier Source: org_study_id
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