NCT03760926已完成不适用
ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)
May Health12 个研究点 分布在 3 个国家目标入组 28 人开始时间: 2019年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.
研究概览
简要总结
The objective of this study is to provide preliminary evidence for the safety and effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for female participants:
- •Age: ≥ 18 to ≤ 40 years
- •Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as:
- •2.1 Infertility associated with chronic anovulation or oligomenorrhea, defined as spontaneous intermenstrual periods of ≥35 days or a total of ≤9 menses per year 2.2 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or follicle number per ovary of ≥ 20) 2.3 Evidence of hyperandrogenaemia: either clinical (hirsutism or acne) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)
- •Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
- •Resistance to first-line pharmacological treatment, defined as at least 2 consecutive non-ovulatory cycles, including at least 1 cycle at the highest dose deemed clinically relevant for the patient
- •At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
- •Willing to comply with protocol-specified follow-up evaluation
- •Signed informed consent
- •Couple inclusion criteria:
- •Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL, motility A+B ⩾ 32%, normal forms ⩾ 4%).
- •Ability to have regular intercourse during the study
- •No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed
- •Candidates will be excluded from the study if ANY of the following conditions apply:
- •Pregnant, parturient or breastfeeding women
- •Marked obesity, BMI > 35
- •Marked hyperandrogenism (FAI > 15)
- •Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.
- •Subject with pacemaker, defibrillator or other active implant
- •Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
- •Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)
排除标准
- 未提供
结局指标
主要结局
Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.
时间窗: During procedure
Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications
时间窗: Up to 30 days
次要结局
- Occurrence of ovulation following the procedure(Up to 3 months after procedure)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault ProlapseUrinary Incontinence, StressMixed IncontinenceVaginal Vault ProlapseNCT00223106Medtronic - MITG467
已完成
不适用
Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and NeckSkin LaxityNCT01708512Ulthera, Inc21
尚未招募
不适用
Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy ProcedureEnteral and Supplement Feeds Adverse ReactionSafety IssuesComplications JejunostomyNCT06095804CoapTech10
已完成
2 期
Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With SchizophreniaSchizophreniaNCT01323205Janssen Research & Development, LLC100
已完成
不适用
Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the NeckWrinklesNCT02368925Seoul National University Hospital18