[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100139050":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":7,"locations":20,"responsibleParty":34,"collaborators":36,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":7,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":7,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":63,"whyStopped":7,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Merck KGaA, Darmstadt, Germany","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Recombinant-follicle stimulating hormone (r-FSH)","The dosage and administration of r-FSH will be in accordance with the PFS and current clinical practice in the centers (300 IU\u002F0.5 ml \\[22 micrograms\u002F0.5 ml\\]; 450 IU\u002F0.75 ml \\[33 micrograms\u002F0.75 ml\\]; or 900 IU\u002F1.5 ml \\[66 micrograms\u002F1.5 ml\\].\n\nThe dosage and administration of recombinant-hCG (r-hCG; 250 micrograms\u002F0.5 ml), injectable solution in a pre-filled syringe will also be in accordance with the PFS and current clinical practice in the centers (only if the doctor decides to start treatment with r-hCG).",[14],"GONAL-f™",[16],{"name":17,"affiliation":18,"role":19},"Medical Responsible","Merck N.V.-S.A., Belgium","STUDY_DIRECTOR",[21],{"facility":22,"status":7,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"ZNA Middelheim","Antwerp","Lindendreef 1","B-2020","Belgium","BE",{"type":29,"coordinates":30},"Point",[31,32],4.40026,51.22047,{"lat":32,"lon":31},{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[37],{"name":18,"class":38},"OTHER","100139050","an-observational-study-to-compare-the-dose-of-gonal-ftm-fbm-prescribed-by-the-doctor-with-the-recommendation-of-the-dose-calculator-consort-and-to-evaluate-the-ease-of-use-of-pre-filled-pen-of-gonal-ftm-fbm-pen-100139050",false,"NCT01080729","An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen","A Prospective, Observational and Multicentric Study to Compare the Dose of GONAL-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of GONAL-fTM FbM Pen","Inclusion Criteria:\n\n* Female subjects who started treatment with Gonal-f on the basis of the decision of the investigator and indications and recommendations of the PFS\n* Subjects who were at least 35 years old when the Gonal-f dose was administered (i.e. at the time of introducing individual variables of the subject in the CONSORT calculator for determining the dose)\n* Subjects with BMI \\\u003C 30 kg\u002Fm2\n* Subjects who were in premature follicle phase (day 2-4), basal FSH ≤12 IU\u002Fl (measured in the center's laboratory)\n* Subjects who were taking a gonadotropin-releasing hormone (GnRH) protocol agonist\n* Subjects who consented to participate in the study and inform the investigator about their medical history\n* Subjects who signed the written consent form, which stipulated that the subject could dropout of the study at any time without any negative consequences on future medical treatments\n\nExclusion Criteria:\n\n* Subjects simultaneously participating in an interventional study\n* Subjects following concomitant treatment with clomifene citrate\n* Subjects presenting one of the contraindications described in the SPC","FEMALE","18 Years","35 Years",{"count":50,"type":51},25,"ACTUAL","OBSERVATIONAL","This is a prospective, observational and multicentric study to compare the Gonal-f FbM (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT (Consistency in r-FSH Starting doses for individualized treatment) calculator.",[55],"Multifollicular Stimulation",[57,58,59,60,61,62],"Ovulation induction","Ovarian Hyperstimulation Syndrome","Multifollicular stimulation","Pregnancy","Sperm injections, intracytoplasmic","Fertility","TERMINATED","2014-07-01",{"date":66,"type":67},"2014-07-02","ESTIMATED",{"date":69,"type":7},"2009-02",{"date":71,"type":51},"2010-02",{"name":5,"class":6},1]