NCT03760926Completed
A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility
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)
Source: ClinicalTrials.gov · Last updated 27 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 21 Nov 2018
- Start date
- 14 Feb 2019
- Primary completion date
- 2 Sept 2023
- Lead sponsor
- May Health
- NCT number
- NCT03760926
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 14 Feb 2019 to the primary completion date, 2 Sept 2023
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Criteria the registry did not label
- Candidates for this study must meet ALL of the following criteria:
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| CU Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Bicetre Hospital Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Liverpool Women Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.