A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visu… (NCT03760926) | Clinical Trial Compass
CompletedNot Applicable
A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility
Belgium, France, United Kingdom28 participantsStarted 2019-02-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: ≥ 18 to ≤ 40 years
. Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as:
.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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Up to 30 days
2
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.
. 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