[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611588":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":87,"studyPopulation":16,"armGroups":88,"interventions":101,"overallOfficials":109,"centralContacts":114,"locations":123,"responsibleParty":195,"collaborators":16,"id":197,"slug":16,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":198,"sex":204,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":16,"studyType":210,"phases":211,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":171,"whyStopped":16,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},{"fullName":5,"class":6},"Fundacion Dexeus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Number of good quality blastocysts (GQB)","(ASEBIR criteria","Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60,64,67,70,74,76,79],{"measure":15,"description":16,"timeFrame":17},"Days of stimulation",null,"From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.",{"measure":19,"description":16,"timeFrame":20},"Total dose of Gonadotropins","From first day of ovarian stimulation to trigger day (8-12 days total).",{"measure":22,"description":16,"timeFrame":23},"Number COCs","Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger.",{"measure":25,"description":16,"timeFrame":26},"Number MII","Assessed on same day as oocyte retrieval, after denudation and classification",{"measure":28,"description":16,"timeFrame":29},"Fertilization rate","Assessed on Day 1 after ICSI, 16-18 hours post-injection",{"measure":31,"description":16,"timeFrame":32},"Time of appearance of the 2nd polar body (tPB2)","Recorded via time-lapse system, within first 8 hours post-ICSI (Day 0).",{"measure":34,"description":16,"timeFrame":35},"Time of pronuclei appearance (tPNa)","Measured on Day 1 post-ICSI using time-lapse monitoring.",{"measure":37,"description":16,"timeFrame":38},"Evaluation of both pronuclei (PN)","Assessed during pronuclear stage on Day 1 post-ICSI.",{"measure":40,"description":16,"timeFrame":41},"Time of pronuclei disappearance (tPNf)","Recorded by time-lapse imaging, approx. 20-24 hours post-ICSI.",{"measure":43,"description":16,"timeFrame":44},"Time of division from 2 to 8 cells","Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI",{"measure":46,"description":16,"timeFrame":47},"Time of compaction (tSC)","Tracked by time-lapse imaging on Day 4 post-ICSI",{"measure":49,"description":16,"timeFrame":50},"Time of morula (tM)","Recorded by time-lapse on Day 4 post-ICSI.",{"measure":52,"description":16,"timeFrame":53},"Time of cavitation (tSB)","Recorded by time-lapse on Day 5 post-ICSI.",{"measure":55,"description":16,"timeFrame":56},"Time of full blastulation (tB)","Measured by time-lapse on Day 5 of embryo culture",{"measure":58,"description":16,"timeFrame":59},"Total number of day 5 blastocysts","Counted on Day 5 of embryo culture after ICSI",{"measure":61,"description":62,"timeFrame":63},"Blastocyst formation rate,","the proportion of 2PN zygotes that reach the blastocyst stage","Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.",{"measure":65,"description":16,"timeFrame":66},"Number of embryos cryopreserved","Recorded at time of freezing on Day 5-7 of embryo culture",{"measure":68,"description":16,"timeFrame":69},"Embryo stage (D5, D6, D7)","Assessed at time of embryo cryopreservation on Day 5 to 7",{"measure":71,"description":72,"timeFrame":73},"Change in AFC","before and after the treatment with semaglutide","Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).",{"measure":75,"description":72,"timeFrame":73},"Change in AMH",{"measure":77,"description":72,"timeFrame":78},"Change in BMI",": Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).",{"measure":80,"description":72,"timeFrame":78},"Change in WC",{"allocation":82,"interventionModel":83,"interventionModelDescription":16,"primaryPurpose":84,"observationalModel":16,"timePerspective":16,"maskingInfo":85},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":86,"maskingDescription":16,"whoMasked":16},"NONE","Overweight and obese women (BMI 27-40 kg\u002Fm²) aged ≤38 years with adequate ovarian reserve (AMH ≥1 ng\u002FmL or AFC ≥6) will be enrolled. Participants will be randomized in a 1:1 ratio to receive either 12 weeks of semaglutide pre-treatment (intervention group) or no pre-treatment (control group) before undergoing standard ovarian stimulation.\n\nEmbryos will be cultured to the blastocyst stage and cryopreserved (freeze-all strategy). In the semaglutide group, embryo transfer will occur after an 8-week washout from the last semaglutide dose.\n\nPrimary outcome: number of good-quality blastocysts on day 5. Secondary outcomes: embryo morphokinetics, fertilization rate, number of MII oocytes, number of COCs, total blastocyst formation rate, number of cryopreserved embryos, and pre\u002Fpost semaglutide changes in weight, BMI, waist circumference, AMH, and AFC.\n\nThe study has been designed with a superiority hypothesis to detect a difference of 1.5 good-quality blastocysts between groups, with 80% power and a two-sided alpha of 0.05.",[89,95],{"label":90,"type":91,"description":92,"interventionNames":93},"Semaglutide","EXPERIMENTAL","Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation",[94],"Drug: Semaglutide",{"label":96,"type":97,"description":98,"interventionNames":99},"No pre-treatment","ACTIVE_COMPARATOR","No pre-treatment prior to ovarian stimulation Pre-treatment",[100],"Other: No pre-treatment",[102,106],{"type":103,"name":90,"description":104,"armGroupLabels":105,"otherNames":16},"DRUG","Participants in this group will receive semaglutide for 12 weeks before ovarian stimulation (0.25 mg\u002Fweek in weeks 1-4, 0.5 mg\u002Fweek in weeks 5-8, and 1 mg\u002Fweek in weeks 9-12). After pre-treatment, controlled ovarian stimulation will be initiated with 225-300 IU\u002Fday of rFSH, GnRH antagonist (0.25 mg\u002Fday) starting when follicles reach ≥14 mm, and ovulation triggered with triptorelin 0.2 mg when 2-3 follicles reach ≥18 mm. Oocyte retrieval will occur 34-36 hours later, followed by IVF\u002FICSI. Embryos will be cultured to blastocyst stage and cryopreserved. Embryo transfer will occur after an 8-week washout from semaglutide.",[90],{"type":6,"name":96,"description":107,"armGroupLabels":108,"otherNames":16},"Participants in this group will undergo standard ovarian stimulation without semaglutide pre-treatment. Stimulation will begin with 225-300 IU\u002Fday of rFSH, GnRH antagonist (0.25 mg\u002Fday) starting when follicles reach ≥14 mm, and ovulation triggered with triptorelin 0.2 mg when 2-3 follicles reach ≥18 mm. Oocyte retrieval will be performed 34-36 hours later, followed by IVF\u002FICSI. Embryos will be cultured to the blastocyst stage and cryopreserved. Embryo transfer will follow standard clinical practice.",[96],[110],{"name":111,"affiliation":112,"role":113},"Nikolaos P Polyzos, MD, PhD","Dexeus Fertility","PRINCIPAL_INVESTIGATOR",[115,119],{"name":111,"role":116,"phone":117,"phoneExt":16,"email":118},"CONTACT","0034932274700","nikpol@dexeus.com",{"name":120,"role":116,"phone":117,"phoneExt":121,"email":122},"Ignacio Rodríguez, MSc","22029","nacrod@dexeus.com",[124,142,154,169,183],{"facility":125,"status":126,"city":127,"state":128,"zip":16,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":137},"Dexeus Mujer Sabadell","NOT_YET_RECRUITING","Sabadell","Barcelona","Spain","ES",{"type":132,"coordinates":133},"Point",[134,135],2.10942,41.54329,{"lat":135,"lon":134},[138,141],{"name":139,"role":116,"phone":117,"phoneExt":16,"email":140},"Ainhoa Coco, MD","aincoc@dexeus.com",{"name":139,"role":113,"phone":16,"phoneExt":16,"email":16},{"facility":143,"status":126,"city":144,"state":128,"zip":145,"country":129,"countryCode":130,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Dexeus Mujer Sant Cugat","Sant Cugat del Vallès","08195",{"type":132,"coordinates":147},[148,149],2.08611,41.47063,{"lat":149,"lon":148},[152,153],{"name":139,"role":116,"phone":117,"phoneExt":16,"email":140},{"name":139,"role":113,"phone":16,"phoneExt":16,"email":16},{"facility":155,"status":126,"city":156,"state":157,"zip":158,"country":129,"countryCode":130,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Dexeus Mujer Reus","Reus","Tarragona","43202",{"type":132,"coordinates":160},[161,162],1.10687,41.15612,{"lat":162,"lon":161},[165,168],{"name":166,"role":116,"phone":16,"phoneExt":16,"email":167},"Josep Gonzalo, MD","JOSGON@dexeus.com",{"name":166,"role":113,"phone":16,"phoneExt":16,"email":16},{"facility":170,"status":171,"city":128,"state":16,"zip":172,"country":129,"countryCode":130,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus","RECRUITING","08028",{"type":132,"coordinates":174},[175,176],2.15899,41.38879,{"lat":176,"lon":175},[179,180],{"name":120,"role":116,"phone":117,"phoneExt":121,"email":122},{"name":181,"role":182,"phone":16,"phoneExt":16,"email":16},"Valeria Donno, MD","SUB_INVESTIGATOR",{"facility":184,"status":126,"city":157,"state":16,"zip":185,"country":129,"countryCode":130,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Dexeus Mujer Tarragona","43206",{"type":132,"coordinates":187},[188,189],1.24544,41.11905,{"lat":189,"lon":188},[192,194],{"name":166,"role":116,"phone":16,"phoneExt":16,"email":193},"josgon@dexeus.com",{"name":166,"role":113,"phone":16,"phoneExt":16,"email":16},{"type":196,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100611588",false,"NCT07242534","Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization.","Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization. A Randomized Controlled Trial","SEQ","Inclusion Criteria:\n\n* ≤ 38 years\n* AMH \\>= 1 ng\u002FmL or AFC \\>= 6\n* Body mass index (BMI) between 27 kg\u002Fm2 and 40 kg\u002Fm2\n* Scheduled for IVF with freeze-all strategy\n\nExclusion Criteria:\n\n* Severe male factor (sperm concentration \\\u003C5M\u002FmL)\n* Type 2 diabetes mellitus\n* Prior use of GLP-1 Ras within the past year\n* Uncontrolled thyroid disorders\n* Contraindications to IVF or semaglutide treatment\n* Patients with chronic inflammatory diseases\n* Family history of hereditary or chromosomal diseases\n* Use of glucocorticoids or immunosuppressants\n* PGT-A\n* Use of medications affecting metabolism or inflammation","FEMALE","18 Years","38 Years",{"count":208,"type":209},62,"ESTIMATED","INTERVENTIONAL",[212],"PHASE4","This is a randomized, controlled clinical trial with a two-sided superiority hypothesis. The study evaluates whether a 12-week pre-treatment with semaglutide prior to ovarian stimulation improves the number of good-quality blastocysts in overweight and obese women undergoing in vitro fertilization (IVF), compared to no pre-treatment.",[215,216],"Infertility","Obesity",[216,218,219,220,221],"Overweight","GLP-1 receptor agonist","IVF","ART","2026-01-19",{"date":224,"type":225},"2026-01-21","ACTUAL",{"date":222,"type":225},{"date":228,"type":209},"2027-05",{"name":5,"class":6},5]