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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 39
- 主要终点
- Adverse event collection
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Infertility associated with oligo- or anovulation, AND EITHER:
- •2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR
- •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/L, or FAI > 4)
- •At least one ovary with ovarian volume ≥ 10.0 mL and < 28.0 mL
- •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.)
- •At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
- •Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment
- •Currently seeking immediate fertility
- •Willing to comply with Clinical Investigation Plan-specified follow-up evaluations
- •Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form
- •Signed informed consent
排除标准
- •Currently pregnant
- •Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL)
- •Poor glycemic level control defined as glycohemoglobin (HbA1c) level > 6.5%
- •Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.
- •Active genital or urinary tract infection at the time of the procedure
- •Patient with known or suspected periovarian adhesions
- •Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary)
- •Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
- •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
- •Received > 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection)
- •Contraindicated to or known previous reaction to anesthesia or sedation regimen
- •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
- •Male partner's total motile sperm count (TMSC) < 10 million or not available (unless participant is planning donor sperm IUI)
- •Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
- •Known or suspected gynecological malignancy
- •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
研究组 & 干预措施
Control arm
No fertility medication. Crossover participants who choose to crossover after the 3 month follow up visit will restart follow up as per the Device arm.
Device arm
May Health procedure performed with the use of the May Health system intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to Polycystic Ovary Syndrome.
干预措施: May Health System (Device)
结局指标
主要结局
Adverse event collection
时间窗: Day 0 through 36 month visit
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/or the procedure, and whether anticipated
Ovulation occurrence
时间窗: 3 month follow-up
Occurrence of at least one (1) ovulation
Adverse event collection
时间窗: Day 0 through 36 month visit
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/or the procedure, and whether anticipated
次要结局
- Hormone serum concentrations(Baseline through 36 month visit)
- Cumulative ovulation rate at 6 months without 1st-line medication(Device arm and Crossover at 6 month visit)
- Cumulative ovulation rate at 6 months with 1st-line(Device arm and Crossover at 6 month visit)
- Time to ovulation(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)
- Documented pregnancy(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)
- Hormone serum concentrations(Baseline through 36 month visit)
- Pain level after procedure(Device arm and Crossover - Baseline through 7 day visit)
- Performance of activities of daily living(Device arm and Crossover: baseline, 24 hours post procedure, D7)
- Procedure times(Device arm and Crossover at Day 0)
- Time to discharge(Device arm and Crossover at Day 0)
- Modified Post Anaesthetic Discharge Scoring System (PADSS)(Device arm and Crossover at 1 hour, 2 hour post procedure)