[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658945":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":71,"studyPopulation":63,"armGroups":72,"interventions":81,"overallOfficials":96,"centralContacts":100,"locations":106,"responsibleParty":120,"collaborators":122,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":63,"studyType":140,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":162,"whyStopped":63,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"New Hope Fertility Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":63},[9],{"measure":10,"description":11,"timeFrame":12},"Maturation Rate to Metaphase II (MII) Following CAPA-IVM","Proportion of immature oocytes retrieved from the CAPA-IVM ovary that reach the metaphase II (MII) stage after completion of the biphasic CAPA-IVM culture process. Maturation rate will be calculated as the number of oocytes reaching MII divided by the number of immature oocytes undergoing CAPA-IVM.","Up to approximately 54 hours after initiation of CAPA-IVM culture",[14,18,22,26,29,33,37,41,45,49,53,56,60],{"measure":15,"description":16,"timeFrame":17},"Fertilization Rate","Proportion of injected MII oocytes showing normal two-pronuclear (2PN) fertilization after ICSI, analyzed by ovary\u002Ftreatment origin.","At fertilization assessment following ICSI",{"measure":19,"description":20,"timeFrame":21},"Cleavage Rate","Proportion of normally fertilized embryos that undergo cleavage by embryo culture Day 2-3.","Day 2-3 after fertilization",{"measure":23,"description":24,"timeFrame":25},"Blastocyst Formation Rate","Proportion of embryos developing to the blastocyst stage, analyzed according to CAPA-IVM or minimal-stimulation OS-IVF origin.","Day 5-6 after fertilization",{"measure":27,"description":28,"timeFrame":25},"High-Quality Blastocyst Rate","Proportion of embryos meeting the center's predefined criteria for high-quality blastocyst morphology.",{"measure":30,"description":31,"timeFrame":32},"Clinical Pregnancy Rate","Proportion of embryo transfers resulting in a clinical pregnancy confirmed by ultrasound evidence of fetal cardiac activity.","Approximately 7-8 weeks gestation",{"measure":34,"description":35,"timeFrame":36},"Ongoing Pregnancy Rate","Proportion of embryo transfers resulting in an ongoing pregnancy beyond 12 weeks gestation.","Greater than 12 weeks gestation",{"measure":38,"description":39,"timeFrame":40},"Live Birth Rate","Proportion of embryo transfers resulting in a live birth. Outcomes will be analyzed according to embryo origin when traceable.","At delivery, up to approximately 10 months after embryo transfer",{"measure":42,"description":43,"timeFrame":44},"Procedure-Related and Treatment-Related Adverse Events","Incidence of adverse events including ovarian hyperstimulation syndrome, egg-retrieval complications, sedation\u002Fanesthesia complications, and other study-related adverse events.","From initiation of study treatment through 6 months after treatment",{"measure":46,"description":47,"timeFrame":48},"Change in Serum Anti-Müllerian Hormone (AMH)","Change in serum AMH concentration from baseline to the follow-up ovarian-reserve assessment.","Baseline and 3-6 months after treatment",{"measure":50,"description":51,"timeFrame":52},"Gestational Age at Delivery","Gestational age at delivery among live-born infants resulting from embryos included in the study.","At delivery",{"measure":54,"description":55,"timeFrame":48},"Change in Antral Follicle Count (AFC)","Change in antral follicle count from baseline to the follow-up ovarian-reserve assessment.",{"measure":57,"description":58,"timeFrame":59},"Birth Weight","Birth weight of live-born infants resulting from embryos included in the study.","At birth",{"measure":61,"description":62,"timeFrame":59},"Reported Congenital Anomalies","Number and proportion of live-born infants with one or more congenital anomalies documented at birth.",null,{"allocation":65,"interventionModel":66,"interventionModelDescription":67,"primaryPurpose":68,"observationalModel":63,"timePerspective":63,"maskingInfo":69},"NA","SINGLE_GROUP","All participants undergo the same prospective within-patient paired comparison. The right ovary is assigned to CAPA-IVM and the left ovary is assigned to minimal-stimulation OS-IVF. Immature oocytes are retrieved from the right ovary for CAPA-IVM beginning on or after menstrual cycle Day 3, before ovarian stimulation. Minimal stimulation of the left ovary begins on Day 5 of the same menstrual cycle, followed by oocyte retrieval and standard IVF\u002FICSI. Outcomes are compared according to ovary and oocyte origin, with each participant serving as her own internal control.","TREATMENT",{"masking":70,"maskingDescription":63,"whoMasked":63},"NONE","This is a prospective, within-patient comparative study in women undergoing fertility treatment. Each participant serves as her own internal control. At the Day 3 baseline visit, the right ovary is assigned to the CAPA-IVM approach and the left ovary is assigned to minimal controlled ovarian stimulation followed by IVF\u002FICSI. Both approaches are performed within the same menstrual cycle.\n\nFor the CAPA-IVM arm, immature oocytes are retrieved from the right ovary beginning on or after menstrual cycle Day 3, before ovarian stimulation is initiated. The right ovary is not stimulated and does not receive an ovulation trigger before oocyte collection. Retrieved cumulus-oocyte complexes are handled separately, and immature oocytes at the germinal vesicle (GV) or metaphase I (MI) stage undergo a biphasic CAPA-IVM process consisting of an initial pre-maturation\u002Fcapacitation phase followed by transfer to maturation conditions and assessment for development to the metaphase II (MII) stage.\n\nAfter completion of right-ovary aspiration, minimal controlled ovarian stimulation of the left ovary begins on Day 5. The protocol uses clomiphene citrate for approximately 9 days and follitropin beta for approximately 3 days, with ultrasound and\u002For hormonal monitoring. Final oocyte maturation is initiated with leuprolide acetate as a GnRH-agonist trigger, followed by routine oocyte retrieval from the left ovary.\n\nMature oocytes obtained from both approaches may undergo ICSI according to New Hope Fertility Center clinical practice. Oocyte assessment and selection for ICSI, ICSI itself, and standard embryo culture are considered clinical procedures; the research-specific component is the CAPA-IVM maturation approach and the within-patient comparison of outcomes according to ovary of origin. Oocytes and embryos are tracked separately to maintain traceability throughout fertilization, embryo culture, and subsequent clinical outcomes.\n\nThe primary endpoint is the proportion of immature CAPA-IVM oocytes that mature to the MII stage. Secondary endpoints include fertilization rate, cleavage, blastocyst formation, high-quality blastocyst formation, implantation, clinical pregnancy, ongoing pregnancy, live birth, neonatal outcomes, and safety outcomes including procedure-related complications and ovarian reserve measures.",[73],{"label":74,"type":75,"description":76,"interventionNames":77},"Within-Patient CAPA-IVM and Minimal-Stimulation OS-IVF","EXPERIMENTAL","All participants undergo a within-patient comparison in the same menstrual cycle. The right ovary undergoes retrieval of immature oocytes for CAPA-IVM beginning on or after menstrual cycle Day 3, before ovarian stimulation. The left ovary subsequently undergoes minimal controlled ovarian stimulation beginning on Day 5, followed by oocyte retrieval and standard IVF\u002FICSI. Outcomes are compared according to ovary and oocyte origin, with each participant serving as her own internal control.",[78,79,80],"Procedure: CAPA-IVM","Device: In-House CAPA-IVM Pre-Maturation Medium","Procedure: Minimal-Stimulation OS-IVF",[82,87,92],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":63},"PROCEDURE","CAPA-IVM","Immature cumulus-oocyte complexes are retrieved from the right ovary before ovarian stimulation and undergo a biphasic CAPA-IVM process. The first phase is a pre-maturation\u002Fcapacitation culture intended to maintain meiotic arrest while supporting developmental competence. Oocytes are then transferred to maturation conditions and assessed for maturation to metaphase II (MII). Mature oocytes may subsequently undergo ICSI and standard embryo culture according to clinical practice.",[74],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":63},"DEVICE","In-House CAPA-IVM Pre-Maturation Medium","An investigational in-house reproductive culture medium is used during the pre-maturation\u002Fcapacitation phase of CAPA-IVM for immature cumulus-oocyte complexes. The proprietary formulation is prepared for use in the CAPA-IVM laboratory procedure. Following the pre-maturation phase, oocytes are transferred to maturation conditions and assessed for MII maturation.",[74],{"type":83,"name":93,"description":94,"armGroupLabels":95,"otherNames":63},"Minimal-Stimulation OS-IVF","After completion of right-ovary CAPA-IVM aspiration, minimal controlled ovarian stimulation of the left ovary begins on menstrual cycle Day 5. The regimen includes clomiphene citrate for approximately 9 days and follitropin beta for approximately 3 days with ultrasound and\u002For hormonal monitoring. Final oocyte maturation is initiated using leuprolide acetate as a GnRH-agonist trigger. Oocytes are subsequently retrieved from the left ovary and undergo standard IVF\u002FICSI and embryo culture according to clinical practice.",[74],[97],{"name":98,"affiliation":5,"role":99},"John J Zhang, M.D. Ph.D","PRINCIPAL_INVESTIGATOR",[101],{"name":102,"role":103,"phone":104,"phoneExt":63,"email":105},"Clinical Coordinators","CONTACT","212-969-7461","coordinators@nhfc.com",[107],{"facility":5,"status":63,"city":108,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"New York","10021","United States","US",{"type":113,"coordinates":114},"Point",[115,116],-74.00597,40.71427,{"lat":116,"lon":115},[119],{"name":102,"role":103,"phone":104,"phoneExt":63,"email":105},{"type":121,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR",[123],{"name":124,"class":125},"Embryotools","UNKNOWN","100658945","intra-ovarian-capa-ivm-vs-standard-ivm-100658945",false,"NCT07858435","Intra-ovarian CAPA-IVM vs Standard IVM","A Within-Patient Comparison of CAPA-IVM (Biphasic Capacitation IVM) With the Contralateral Ovary Undergoing Minimal Controlled Ovarian Stimulation (OS-IVF)","IO-CAPA","Inclusion Criteria:\n\n* Female, age 18 to 38 years.\n* Undergoing assisted reproductive treatment for infertility.\n* Both ovaries present and anatomically suitable for oocyte retrieval, with no prior oophorectomy.\n* Adequate ovarian reserve for study participation, including AMH greater than 0.5 ng\u002FmL and antral follicle count greater than 6 per ovary.\n* Both ovaries considered suitable for their assigned study procedures: right ovary for CAPA-IVM and left ovary for minimal-stimulation OS-IVF.\n* Access to partner or donor sperm for fertilization\u002FICSI according to clinic protocol.\n* Willing and able to provide written informed consent and comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Severe endometriosis, Stage III or IV.\n* Known diminished ovarian reserve with AMH less than 0.2 ng\u002FmL, unless specifically permitted under an approved study amendment.\n* Active pelvic infection.\n* Untreated hydrosalpinx.\n* Known chromosomal abnormality in either reproductive partner, unless appropriate genetic testing is planned.\n* Contraindication to oocyte retrieval or sedation\u002Fanesthesia.\n* Any medical or gynecologic condition that, in the investigator's judgment, would interfere with study participation, oocyte retrieval, study procedures, or participant safety.","FEMALE","18 Years","38 Years",{"count":138,"type":139},20,"ESTIMATED","INTERVENTIONAL",[65],"This prospective study compares two approaches to obtaining mature oocytes for fertility treatment within the same participant. Immature oocytes are first retrieved from the right ovary and matured in the laboratory using a two-step biphasic capacitation in vitro maturation method (CAPA-IVM). Beginning on Day 5 of the same menstrual cycle, the left ovary undergoes minimal controlled ovarian stimulation followed by routine oocyte retrieval and IVF\u002FICSI.\n\nThe primary objective is to evaluate the maturation of CAPA-IVM oocytes to the metaphase II (MII) stage and compare reproductive laboratory outcomes between the CAPA-IVM and minimal-stimulation OS-IVF approaches. Secondary outcomes include fertilization, embryo development, blastocyst formation, embryo quality, pregnancy and live birth outcomes, and safety.",[144,145,146],"Infertility (IVF Patients)","Infertility","Infertility Female",[148,149,84,150,151,152,153,154,155,156,157,158,159,160,161],"In Vitro Maturation","IVM","Biphasic In Vitro Maturation","Oocyte Maturation","Oocyte","Assisted Reproductive Technology","IVF","ICSI","Minimal Ovarian Stimulation","Controlled Ovarian Stimulation","Embryo Development","Blastocyst Formation","Female Infertility","Within-Patient Comparison","NOT_YET_RECRUITING","2026-09-29",{"date":165,"type":166},"2026-10-05","ACTUAL",{"date":168,"type":139},"2026-10",{"date":170,"type":139},"2027-10",{"name":5,"class":6},1]