NCT05320289已完成不适用
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome
May Health2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年5月12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
- 5
- 试验地点
- 2
- 主要终点
- Occurrence of at least one (1) ovulation between treatment and 3-month visit.
研究概览
简要总结
The objective of the study is to provide preliminary evidence for the safety and effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under ultrasound visualization 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.
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
- •Age: ≥ 18 to ≤ 40 years
- •Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria: Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:
- •Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral follicle count per ovary ≥ 20) OR 2.
- •Evidence of hyperandrogenaemia: either clinical (hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)
- •At least one ovary with ovarian volume ≥ 10ml
- •Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
- •Failure to respond to first-line pharmacological treatment or is contraindicated for or decline such treatment.
- •At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
- •Willing to comply with Clinical Investigation Plan-specified follow-up evaluation
- •Ability to understand study requirements and has sufficient fluency in one of the IRB-approved written translation of the Patient Information and Informed consent form
- •Signed informed consent
- •Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL, total motility ≥ 40%, normal morphology ≥ 4%) within the last year
- •Ability to have regular vaginal intercourse during the study
- •No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed
排除标准
- •Current pregnancy
- •Marked obesity, BMI > 40
- •Marked hyperandrogenism (FAI > 15)
- •Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
- •Patient not willing to stop all concomitant first-line oral medications at least 6 weeks prior to study procedure and until the 3-month endpoint is reached, and all other forms of ovulation-induction treatment until the 6-month endpoint is reached
- •Lack of capacity to give informed consent
- •Lack of capacity to follow Clinical Investigation Plan and study requirements including all study follow-up visits
- •Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery, ovarian cysts surgery
- •Patient with known or suspected periovarian adhesions
- •Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries
结局指标
主要结局
Occurrence of at least one (1) ovulation between treatment and 3-month visit.
时间窗: 3 months
次要结局
- 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.(During procedure)
- Occurrence of at least one (1) ovulation between treatment and the 6-month visit with or without 1st line medication 3 months or more post-procedure(6 months)
研究者
研究点 (2)
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