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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called the AblaCare System to assist women with infertility due to polycystic ovary syndrome (PCOS). The researchers aim to determine if using the system to perform a procedure on the ovaries can safely and effectively help women who haven't succeeded with other treatments. Women who haven't responded to or can't take first-line ovulation treatments and have PCOS-related infertility might be suitable candidates. The procedure uses ultrasound to guide the treatment on ovarian tissue. As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research that could lead to new infertility solutions.

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 prior data suggests that the AblaCare System is safe for transvaginal ablation of ovarian tissue?

Research shows that the AblaCare System, used for transvaginal ablation (removing small parts of the ovary with ultrasound), is under study for safety and effectiveness. Previous studies have tested its efficacy and safety. These studies are crucial for assessing patient tolerance and identifying any side effects.

Results so far suggest that patients generally undergo the procedure without serious issues. However, as research continues, more information is needed to fully understand the AblaCare System's safety. Prospective trial participants should discuss any concerns and questions with the research team to better understand potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AblaCare System is unique because it offers a new approach to treating infertility caused by polycystic ovary syndrome (PCOS). Unlike standard treatments like medications that stimulate ovulation or lifestyle changes, this system uses transvaginal ablation of ovarian tissue. This method involves precisely targeting and treating ovarian tissue under ultrasound guidance, potentially addressing the root cause of infertility more directly. Researchers are excited because this technique could provide a more effective solution for women with PCOS who struggle to conceive, offering a new hope where traditional methods might have limited success.

What evidence suggests that the AblaCare System is effective for PCOS?

Research has shown that the AblaCare System, which participants in this trial will receive, may assist women with polycystic ovary syndrome (PCOS) who struggle to conceive. In a small study involving 23 women with PCOS who did not respond to the usual treatment, clomifene citrate, 86.4% began ovulating regularly within six months after using the AblaCare System. This indicates that most participants were able to release an egg, a crucial step toward pregnancy. The AblaCare System employs a method based on a proven surgical technique but is less invasive, potentially making it safer and easier for patients. These early results suggest that the AblaCare System could be an effective option for women with PCOS who wish to have a baby. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• AblaCare System

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05320289

Feasibility Study of the AblaCare System in Transvaginal ... The objective of the study is to provide preliminary evidence for the safety and effectiveness of the AblaCare System in transvaginal ablation of ovarian ...

2. withpower.com withpower.com/trial/phase-infertility-3-2022-53b26

AblaCare System for Polycystic Ovary Syndrome In a pilot study of 23 anovulatory women with clomifene-citrate-resistant PCOS, 86.4% achieved regular ovulation within 6 months after undergoing ultrasound- ...

3. pharmacompass.com pharmacompass.com/pdf/party/content/ablacare-party-content-1563951763.pdf

Minimally invasive treatment of PolyCystic Ovary Syndrome ... AblaCare is developing a device for the treatment of PCOS related infertility, based on an effective and demonstrated surgical predicate and an access and ...

4. clinicaltrial.be clinicaltrial.be/en/details/66201?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Trial of the May Health Device in Transvaginal Ablation... 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 ...

5. fertstert.org fertstert.org/article/S0015-0282(23)01615-1/fulltext

THE ULTRA TRIAL: TRANSVAGINAL ULTRASOUND ... The novel May Health TVUS-guided ovarian ablation System can be an effective method for restoring ovulation in women with PCOS desiring pregnancy.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459251/

Polycystic Ovarian Syndrome - StatPearls - NCBI Bookshelf Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder among females of reproductive age worldwide.