AblaCare System for Polycystic Ovary Syndrome

(ULTRA-US Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: May Health

Must not be taking: First-line oral medications

Disqualifiers: Pregnancy, Obesity, Hyperandrogenism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of the AblaCare System, a device that helps doctors remove small parts of the ovary using ultrasound, in women with PCOS who have trouble getting pregnant and haven't had success with other treatments.

Will I have to stop taking my current medications?

Yes, you will need to stop all first-line oral medications at least 6 weeks before the study procedure and until the 3-month endpoint is reached. You must also stop all other forms of ovulation-induction treatment until the 6-month endpoint is reached.

What data supports the effectiveness of the AblaCare System treatment for polycystic ovary syndrome?

Research shows that similar treatments, like transvaginal ultrasound-guided ovarian interstitial laser treatment, have been effective in improving ovulation in women with polycystic ovary syndrome who do not respond to other medications. ^{1 2 3 4 5}

How does the AblaCare System treatment for PCOS differ from other treatments?

The AblaCare System is unique because it likely involves a minimally invasive procedure, possibly similar to transvaginal, ultrasound-guided treatments, which directly target the ovaries to improve ovulation, unlike common treatments like oral contraceptives that manage symptoms hormonally. ^{4 5 6 7 8}

Eligibility Criteria

Inclusion Criteria

Signed informed consent

At least one ovary with ovarian volume ≥ 10ml

You have been diagnosed with Polycystic Ovary Syndrome (PCOS) based on certain symptoms, such as irregular periods or difficulty getting pregnant.

Exclusion Criteria

Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery, ovarian cysts surgery

Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries

Current pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the AblaCare Procedure for transvaginal ablation of ovarian tissue under ultrasound visualization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the AblaCare Procedure

12 weeks

Treatment Details

Interventions

• AblaCare System

Participant Groups

Group I: AblaCare Procedure Experimental Treatment 1 Intervention

AblaCare Procedure performed with use of the AblaCare Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

Who Is Running the Clinical Trial?

May Health

Lead Sponsor

Trials

3

Recruited

230+

AblaCare

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

In a pilot study of 23 anovulatory women with clomifene-citrate-resistant PCOS, 86.4% achieved regular ovulation within 6 months after undergoing ultrasound-guided, transvaginal, ovarian laser treatment.

The treatment significantly improved hormonal profiles, with marked reductions in serum LH and testosterone levels, and resulted in a cumulative pregnancy rate of 36%, indicating its efficacy and safety for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal, ultrasound-guided, ovarian, interstitial laser treatment in anovulatory women with clomifene-citrate-resistant polycystic ovary syndrome. Zhu, WJ., Li, XM., Chen, XM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Trust in Physicians and Medical Experience Beliefs Differ Between Women With and Without Polycystic Ovary Syndrome. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis of assistant treatment proposals for infertile women with polycystic ovary syndrome]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Polycystic ovary syndrome: current infertility management. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Transvaginal, ultrasound-guided, ovarian, interstitial laser treatment in anovulatory women with clomifene-citrate-resistant polycystic ovary syndrome. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Repeat transvaginal ultrasound-guided ovarian interstitial laser treatment improved the anovulatory status in women with polycystic ovarian syndrome. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: the Rotterdam criteria are premature. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Normalizing Ovulation Rate by Preferential Reduction of Hepato-Visceral Fat in Adolescent Girls With Polycystic Ovary Syndrome. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Application of a Standard Cross-Specialty Workup for Diagnosis and Metabolic Screening of Obese Adolescents With Polycystic Ovary Syndrome. [2021]