Polycystic Ovary SyndromeNCT03760926
A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility
A study testing May Health Kit in people with Polycystic Ovary Syndrome, run by May Health at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- May Health Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 14 Feb 2019to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom3 sites
Royal Derby Hospital
Derby, DE22 3NE
Liverpool Women Hospital
Liverpool, L8 7SS
Royal Hallamshire Hospital
Sheffield, S10 2JF
About this study
Official title: 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)
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- May Health Kit
- Keywords
- Anovulatory infertility
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
May Health KitDevice
The intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.
| Study group | Role | What they receive |
|---|---|---|
| May Health Procedure | Experimental | May Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome. Receives: Device: May Health Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 days
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.
Measured: During procedure
Secondary outcomes (1)
Occurrence of ovulation following the procedure
Measured: Up to 3 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start14 Feb 2019
- Primary completion2 Sep 2023
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- May Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saad Amer, MD, PhD, Study director, Derby Royal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760926
- Sponsor's protocol ID
- ULTRA
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2018
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03760926
- Acronym / sponsor ID
- ULTRA
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Anovulatory infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- May HealthIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| May Health Procedure | Experimental | Device: May Health KitMay Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| May Health KitThe intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue. | Device | May Health Procedure |
Primary outcome
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
Time frame: Up to 30 days
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.
Time frame: During procedure
1 secondary outcome
Occurrence of ovulation following the procedure
Time frame: Up to 3 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad Amer, MD, PhD study director
Derby Royal Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing May Health Kit in people with Polycystic Ovary Syndrome, run by May Health at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.