[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06206746":3,"trial-entities:NCT06206746":256,"trial-summary:NCT06206746":261},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":48,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":95,"locations":97,"central_contacts":246,"overall_officials":247,"references":254,"see_also_links":255},"NCT06206746","CR003","The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System","A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women With Infertility Due to Polycystic Ovary Syndrome","ACTIVE_NOT_RECRUITING","2029-09","2026-06","2026-07-24","2024-03-25","May Health","INDUSTRY",true,"A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome","The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.",[19,20],"Polycystic Ovary Syndrome","Infertility, Female",[22,23,24],"PCOS","Infertility related to PCOS","Ovulation restoration","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},195,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","May Health System","The intervention includes the short-term use of the May Health System, which is comprised of three elements: (1) the May Health Needle-Catheter Ablation Device (NCAD) (the Device) a 16 gauge echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secured onto a vaginal ultrasound probe; (2) the May Health Adapter which is clipped onto the ultrasound probe; and (3) the May Health Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use May Health NCAD for ovarian tissue ablation. Once the patient is under conscious sedation, the physician guides the May Health system transvaginally with the use of a transvaginal ultrasound. Once the May Health device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.",[38],"Device arm",[40,44],{"measure":41,"description":42,"timeFrame":43},"Ovulation occurrence","Occurrence of at least one (1) ovulation","3 month follow-up",{"measure":45,"description":46,"timeFrame":47},"Adverse event collection","Adverse events will be collected between and at each study visit after randomization and throughout the duration of the study and analyzed for seriousness, severity, relatedness to the device and\u002For the procedure, and whether anticipated","Day 0 through 36 month visit",[49,53,56,60,64,68,72,76,80,83],{"measure":50,"description":51,"timeFrame":52},"Cumulative ovulation rate at 6 months without 1st-line medication","Cumulative ovulation rate at 6 months, without 1st line medication restarted ≥ 3 months post-procedure","Device arm and Crossover at 6 month visit",{"measure":54,"description":55,"timeFrame":52},"Cumulative ovulation rate at 6 months with 1st-line","Cumulative ovulation rate at 6 months, with 1st line medication restarted ≥ 3 months post-procedure",{"measure":57,"description":58,"timeFrame":59},"Time to ovulation","Between baseline and 3-month follow-up with weekly assessment","Baseline for the control group is day of randomization to the date of first ovulation. Baseline for the treatment group is day of procedure to the date of first ovulation",{"measure":61,"description":62,"timeFrame":63},"Documented pregnancy","Documented pregnancy at any point during the study (participant reported or medical record)","Control Arm, Device Arm, and Crossover group: from baseline to 30 Day, 3 Month; Device Arm and Crossover group only: 6 Month, 12 Month, 24 Month, 36 Month",{"measure":65,"description":66,"timeFrame":67},"Hormone serum concentrations","Anti-Müllerian hormone (AMH) serum concentration (ng\u002FmL); Androstenedione serum concentration (ng\u002FdL); Sex Hormone Binding Globulin (SHBG) (nmol\u002FL); Free Androgen Index (FAI)","Baseline through 36 month visit",{"measure":69,"description":70,"timeFrame":71},"Pain level after procedure","Measured by Visual Analog Scale (VAS) \\[ranked from 0 (no pain) to 10 (worst pain)\\], immediately after procedure completion, prior to discharge, 1-, and 7-day follow-up as well as baseline pain level reported by the participant during menstruation as reference","Device arm and Crossover - Baseline through 7 day visit",{"measure":73,"description":74,"timeFrame":75},"Performance of activities of daily living","Received score from activities of daily living (ADL)","Device arm and Crossover: baseline, 24 hours post procedure, D7",{"measure":77,"description":78,"timeFrame":79},"Procedure times","Includes pre-treatment, treatment, and post-treatment","Device arm and Crossover at Day 0",{"measure":81,"description":82,"timeFrame":79},"Time to discharge","Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU)",{"measure":84,"description":85,"timeFrame":86},"Modified Post Anaesthetic Discharge Scoring System (PADSS)","The Modified Post Anesthetic Discharge Scoring System (PADSS) score is completed after the procedure. The score evaluates whether the participant is safe to go home after anesthesia. It scores 0-2 points in each category (vital signs, activity, nausea\u002Fvomiting, pain, bleeding, intake\u002Foutput), for a maximum score of 10. Discharge can occur with a score of 9 or more and a vital signs score of 2.","Device arm and Crossover at 1 hour, 2 hour post procedure","FEMALE","18 Years","40 Years",false,{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"Inclusion Criteria:\n\n1. Age ≥ 18 to ≤ 40 years\n2. Infertility associated with oligo- or anovulation, AND EITHER:\n\n   2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and\u002For ovarian antral follicle count per ovary ≥ 20) OR\n\n   2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modified Ferriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens, testosterone ≥ 2.5 nmol\u002FL, or FAI \\> 4)\n3. At least one ovary with ovarian volume ≥ 10.0 mL and \\\u003C 28.0 mL\n4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to at least one ovary. (Note: In the situation where only one ovary is appropriately sized according to the preceding criterion, then this requirement applies to the qualifying ovary.)\n5. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy\u002Flaparoscopy within the last 3 years\n6. Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment\n7. Currently seeking immediate fertility\n8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations\n9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form\n10. Signed informed consent\n\nExclusion Criteria:\n\n1. Currently pregnant\n2. BMI \\> 40\n3. Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol\u002FL or 130ng\u002FdL)\n4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level \\> 6.5%\n5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.\n6. Active genital or urinary tract infection at the time of the procedure\n7. Patient with known or suspected periovarian adhesions\n8. Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary)\n9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary\n10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or a follicle, or functional cyst \\>15 mm on transvaginal ultrasound in ovary to be treated\n11. Received \\> 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection)\n12. Contraindicated to or known previous reaction to anesthesia or sedation regimen\n13. Patient not willing to stop all concomitant first-line ovulation induction treatment (clomiphene citrate, letrozole, as well as metformin unless metformin is required for glycemic control) until the 3-month endpoint is reached\n14. Male partner's total motile sperm count (TMSC) \\\u003C 10 million or not available (unless participant is planning donor sperm IUI)\n15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study\n16. Known or suspected gynecological malignancy\n17. General health condition or systemic disease that may contribute to anovulation, infertility, or represent in the opinion of the investigator, a potential increased risk associated with the May Health system",[96],"ADULT",[98,107,114,122,129,137,145,153,161,169,177,185,192,200,208,215,223,231,238],{"facility":99,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"HRC Fertility - Encino","Encino","California","91436","United States",{"lat":105,"lon":106},34.15917,-118.50119,{"facility":108,"city":109,"state":101,"zip":110,"country":103,"geoPoint":111},"UCSF Center for Reproductive Health","San Francisco","94158",{"lat":112,"lon":113},37.77493,-122.41942,{"facility":115,"city":116,"state":117,"zip":118,"country":103,"geoPoint":119},"University of South Florida","Tampa","Florida","33606",{"lat":120,"lon":121},27.94752,-82.45843,{"facility":123,"city":124,"state":117,"zip":125,"country":103,"geoPoint":126},"The IVF Center","Winter Park","32792",{"lat":127,"lon":128},28.6,-81.33924,{"facility":130,"city":131,"state":132,"zip":133,"country":103,"geoPoint":134},"SIU School of Medicine, Reproductive Endocrinology & Infertility Center","Springfield","Illinois","62702",{"lat":135,"lon":136},39.80172,-89.64371,{"facility":138,"city":139,"state":140,"zip":141,"country":103,"geoPoint":142},"University of Iowa Health Care","Iowa City","Iowa","52240",{"lat":143,"lon":144},41.66113,-91.53017,{"facility":146,"city":147,"state":148,"zip":149,"country":103,"geoPoint":150},"Cypress Medical Research Center","Wichita","Kansas","67226",{"lat":151,"lon":152},37.69224,-97.33754,{"facility":154,"city":155,"state":156,"zip":157,"country":103,"geoPoint":158},"Johns Hopkins Fertility Center","Lutherville","Maryland","21093",{"lat":159,"lon":160},39.42122,-76.62608,{"facility":162,"city":163,"state":164,"zip":165,"country":103,"geoPoint":166},"Washington University Fertility and Reproductive Medicine Center","St Louis","Missouri","63110",{"lat":167,"lon":168},38.62727,-90.19789,{"facility":170,"city":171,"state":172,"zip":173,"country":103,"geoPoint":174},"University of Rochester, Strong Fertility Center","Rochester","New York","14623",{"lat":175,"lon":176},43.15478,-77.61556,{"facility":178,"city":179,"state":180,"zip":181,"country":103,"geoPoint":182},"Reach Fertility","Charlotte","North Carolina","28207",{"lat":183,"lon":184},35.22709,-80.84313,{"facility":186,"city":187,"state":180,"zip":188,"country":103,"geoPoint":189},"UNC Fertility","Raleigh","27617",{"lat":190,"lon":191},35.7721,-78.63861,{"facility":193,"city":194,"state":195,"zip":196,"country":103,"geoPoint":197},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"lat":198,"lon":199},35.46756,-97.51643,{"facility":201,"city":202,"state":203,"zip":204,"country":103,"geoPoint":205},"Penn State College of Medicine","Hershey","Pennsylvania","17003",{"lat":206,"lon":207},40.28592,-76.65025,{"facility":209,"city":210,"state":203,"zip":211,"country":103,"geoPoint":212},"Penn Fertility Care","Philadelphia","19104",{"lat":213,"lon":214},39.95238,-75.16362,{"facility":216,"city":217,"state":218,"zip":219,"country":103,"geoPoint":220},"Prisma Health - Upstate","Greenville","South Carolina","29605",{"lat":221,"lon":222},34.85262,-82.39401,{"facility":224,"city":225,"state":226,"zip":227,"country":103,"geoPoint":228},"UT Health San Antonio","San Antonio","Texas","78229",{"lat":229,"lon":230},29.42412,-98.49363,{"facility":232,"city":233,"state":226,"zip":234,"country":103,"geoPoint":235},"Baylor Scott & White Medical Center","Temple","76508",{"lat":236,"lon":237},31.09823,-97.34278,{"facility":239,"city":240,"state":241,"zip":242,"country":103,"geoPoint":243},"UW Health Generations Fertility Care","Middleton","Wisconsin","53562",{"lat":244,"lon":245},43.09722,-89.50429,[],[248,252],{"name":249,"affiliation":250,"role":251},"Karl Hansen, MD, PhD","Oklahoma University Health Sciences Center","PRINCIPAL_INVESTIGATOR",{"name":253,"affiliation":209,"role":251},"Anuja Dokras, MD, PhD",[],[],{"nct_id":4,"conditions":257,"biomarkers":259},[258,19],"Infertility",[260],"Testosterone",{"nct_id":4,"found":15,"summary":262,"prompt_version":272},{"design":263,"status":264,"heading":265,"summary":266,"follow_up":267,"word_count":268,"commitments":269,"compensation":270,"drugs_mentioned":271},"This is a prospective, multicenter, randomized study planning to enroll 195 participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","The REBALANCE Study: May Health System for Infertility due to PCOS","The REBALANCE Study is looking at a new treatment called the May Health System for women aged 18 to 40 who have infertility because of Polycystic Ovary Syndrome (PCOS). This system uses a special needle-catheter device to treat ovarian tissue. The goal is to see if this treatment can help restore ovulation (when an egg is released) and if it is safe. You might be able to join if you have PCOS-related infertility and haven't responded to other treatments, or can't use them. The study will measure if ovulation occurs after 3 months and will track any side effects for up to 36 months. The current recruitment status is unclear.","Participants will be followed for ovulation occurrence at 3 months and for adverse events from the start of the study through a 36-month visit.",110,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]