[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553100":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":60,"centralContacts":65,"locations":74,"responsibleParty":91,"collaborators":35,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":35,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":35,"overallStatus":77,"whyStopped":35,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Andros Day Surgery Clinic","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Resveratrol group","ACTIVE_COMPARATOR","Treatment with resveratrol, folic acid and vitamins B6, B12, D. The duration of treatment will be at least 65 days before the starting of stimulation (from the stage of pre-antral follicles) and until the day of oocyte pick up.",[13,14,15,16,17],"Dietary Supplement: Resveratrol-based multivitamin supplement","Procedure: IVF\u002FICSI","Drug: Follitropin Alfa","Drug: Ganirelix Acetate 0.5 MG\u002FML [Fyremadel]","Drug: hCG 10.000 IU or triptorelin 0,3 mg, subcutaneously",{"label":19,"type":10,"description":20,"interventionNames":21},"Placebo group","Treatment with folic acid only. The duration of treatment will be at least 65 days before the starting of stimulation (from the stage of pre-antral follicles) and until the day of oocyte pick up.",[22,14,15,16,17],"Dietary Supplement: Folic acid",[24,31,36,43,50,54],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIETARY_SUPPLEMENT","Resveratrol-based multivitamin supplement","Natural polyphenol and vitamins",[9],[30],"Genante",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Folic acid","Supplementation with folic acid at the standard dosage of 0.4 mg\u002Fdie",[19],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"PROCEDURE","IVF\u002FICSI","In vitro fertilization\u002FIntraCytoplasmic Sperm Injection",[19,9],[42],"In vitro fertilization",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Follitropin Alfa","Controlled Ovarian Stimulation",[19,9],[49],"Gonal-F",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":35},"Ganirelix Acetate 0.5 MG\u002FML [Fyremadel]","GnRH Antagonist",[19,9],{"type":44,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"hCG 10.000 IU or triptorelin 0,3 mg, subcutaneously","For the induction of oocyte maturation",[19,9],[59],"Gonasi or Decapeptyl",[61],{"name":62,"affiliation":63,"role":64},"Adolfo Allegra, MD","ANDROS Day Surgery Clinic Palermo, Italy","PRINCIPAL_INVESTIGATOR",[66,70],{"name":62,"role":67,"phone":68,"phoneExt":35,"email":69},"CONTACT","0039 091 6785535","adolfo.allegra@clinicaandros.it",{"name":71,"role":67,"phone":72,"phoneExt":35,"email":73},"Angelo Marino, MD","0039 091 6785539","angelo.marino@clinicaandros.it",[75],{"facility":76,"status":77,"city":78,"state":35,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"ANDROS Day Surgery Clinic","RECRUITING","Palermo","90144","Italy","IT",{"type":83,"coordinates":84},"Point",[85,86],13.3636,38.1166,{"lat":86,"lon":85},[89],{"name":71,"role":67,"phone":90,"phoneExt":35,"email":73},"091 6785539",{"type":92,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100553100","possible-action-of-resveratrol-in-improving-the-outcomes-of-ivficsi-in-couples-with-unexplained-infertility-100553100",false,"NCT06481696","Possible Action of Resveratrol in Improving the Outcomes of IVF\u002FICSI in Couples With Unexplained Infertility","Randomized, Placebo-controlled, Double-blind, Single-center Trial to Evaluate the Possible Action of Resveratrol in Improving the Outcomes of Controlled Ovarian Stimulation During the IVF\u002FICSI Cycles in Couples With Unexplained Infertility","RECOS","Inclusion Criteria:\n\n* Female age 18-40 years\n* Female BMI 18-30 kg\u002Fm2\n* normal menstrual cycles (26-35 days)\n* duration of infertility at least 18 months\n* normal semen parameters as established by WHO laboratory manual for the examination and processing of human semen Sixth edition\n* normal US evaluation of male genital anatomy\n* normal FSH, LH, Prolactin, Total Testosterone, Estradiol in male partner\n* bilateral tubal patency established by 3-D HyFoSy or HSG\n* normal uterine cavity evaluated by 3-D HyFoSy or HSG or hysteroscopy\n* absence of antibodies Anti-Chlamyidia Trachomatis IgG\u002FIgM\n* failed intrauterine inseminations or couple's decision to refuse intrauterine inseminations\n\nExclusion Criteria:\n\n* ≥15 cigarettes per day at least in one of the partners\n* irregular menstrual cycles\n* poor ovarian response (on the basis of the \"Bologna\" Criteria)\n* inaccessible ovaries\n* severe endometriosis (stage III-IV of the ASRM revised classification)\n* significant systemic diseases\n* heterologous fertilization\n* previous pelvic surgery\n* presence of ovarian cysts\n* polycystic ovary syndrome\n* use of hormonal contraception in the previous 3 months\n* use of gonadotrophins in the previous 3 months\n* III stage varicocele","FEMALE","18 Years","40 Years",{"count":105,"type":106},90,"ESTIMATED","INTERVENTIONAL",[109],"NA","Based on available evidence and given the potential beneficial effects of resveratrol in folliculogenesis and in oocyte development, the investigators designed a randomized, controlled, double-blind, single-center trial, whose objective will be the comparison of biological and clinical outcomes of resveratrol supplement in women undergoing IVF\u002FICSI cycles for unexplained infertility.\n\nTo the knowledge of the investigators, no study has been published on the potential effect of resveratrol on IVF\u002FICSI outcomes considering couples with this infertility diagnosis, which may be the natural target of this integrative treatment because the process of folliculogenesis and oocyte maturation cannot be routinely investigated. An alteration of these biological mechanisms could be the unrecognized cause of part of the unexplained infertility and treatment with resveratrol could result in significant clinical improvement for the patients enrolled in the study.\n\nIn more details, the main objective of this randomized, placebo-controlled, double-blind, single-center trial will be the evaluation of the possible effect of resveratrol in determining a better follicle development in patients with unexplained infertility undergoing controlled ovarian stimulation (COS) for IVF\u002FICSI.\n\nInfertile female patients with normal ovarian reserve will be treated according to clinical practice and the difference between expected (through AFC) and retrieved oocytes will be assessed in relation to use of resveratrol.",[112],"Unexplained Infertility","2024-06-27",{"date":115,"type":116},"2024-07-01","ACTUAL",{"date":118,"type":116},"2024-06-01",{"date":120,"type":106},"2025-12-31",{"name":5,"class":6},1]