Transvaginal Ablation for Polycystic Ovary Syndrome

Recruiting at 20 trial locations

Overseen By Tracy Rodriguez

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: May Health

Must not be taking: Anticoagulants, Ovulation inducers

Disqualifiers: Pregnancy, BMI > 40, Hyperandrogenism, Poor glycemic control, others

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

Compensation: Varies

Number of Visits: 37

Duration: Day 0

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating infertility in women with Polycystic Ovary Syndrome (PCOS), a condition that can disrupt ovulation. The study examines a procedure using ultrasound to guide a device that treats ovary tissue. Participants will either receive this new treatment from the May Health System or initially not receive any fertility medication, with an option to switch to the treatment later. Women who have tried and not responded to first-line fertility treatments and currently experience irregular ovulation due to PCOS might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for PCOS-related infertility.

Will I have to stop taking my current medications?

You will need to stop taking any first-line ovulation induction treatments like clomiphene citrate, letrozole, or metformin (unless metformin is needed for blood sugar control) until the 3-month endpoint of the study is reached.

What prior data suggests that this device is safe for transvaginal ablation in women with infertility due to Polycystic Ovary Syndrome?

Research shows that the May Health System, used in a procedure called transvaginal ablation to remove or destroy ovarian tissue, is under study to determine its safety and effectiveness for women with polycystic ovary syndrome (PCOS) who have difficulty conceiving. Early results from other studies suggest that patients generally tolerate this system well. Although detailed information about side effects is not yet available, ongoing research aims to fully understand its safety.

The importance of this study indicates some confidence in its safety. However, participants should discuss any concerns with their healthcare providers, who can offer advice tailored to individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transvaginal ablation for Polycystic Ovary Syndrome (PCOS) because it offers a novel, minimally invasive approach to treating infertility associated with the condition. Unlike standard treatments like hormonal therapy or medications that stimulate ovulation, this method directly targets ovarian tissue using ultrasound-guided ablation. This precise technique may help restore fertility more effectively and with fewer side effects than traditional options. By addressing the root cause of infertility in PCOS, this innovative approach has the potential to provide a new pathway to pregnancy for many women.

What evidence suggests that the May Health System is effective for treating infertility due to Polycystic Ovary Syndrome?

Research has shown that using a transvaginal ultrasound (TVUS) to guide ovarian ablation can assist women with polycystic ovary syndrome (PCOS) who struggle with infertility. Studies have found that this procedure can trigger ovulation, a necessary step for pregnancy. In this trial, participants in the device arm will undergo the May Health System procedure, which employs this method and has successfully helped many women with PCOS ovulate regularly again. This treatment is less invasive than traditional methods like laparoscopic ovarian drilling, which is also effective. Early evidence suggests that the May Health System may increase pregnancy rates for those facing infertility due to PCOS. ^{1 2 3 4 6}

Who Is on the Research Team?

Karl Hansen, MD

Principal Investigator

Oklahoma University Health Sciences Center

Anuja Dokras, MD, PhD

Principal Investigator

Penn Fertility Care

Are You a Good Fit for This Trial?

Women aged 18-40 with infertility due to PCOS, who have not responded to first-line treatments or cannot use them. Participants must have at least one accessible ovary and a normal uterine cavity, be currently seeking fertility, and agree to study follow-ups. Exclusions include pregnancy, BMI over 40, severe hyperandrogenism, poor glycemic control, bleeding disorders, active infections around the genital area, previous significant ovarian or tubal surgery.

Inclusion Criteria

Willing to comply with Clinical Investigation Plan-specified follow-up evaluations

I have infertility due to not ovulating properly and either have PCOS shown by ultrasound or high male hormone levels.

I have at least one open fallopian tube and a normal uterus, confirmed by a special test in the last 3 years.

Exclusion Criteria

Contraindicated to or known previous reaction to anesthesia or sedation regimen

I do not have an active genital or urinary tract infection.

I agree to stop all fertility treatments except metformin, if needed for blood sugar control, until the 3-month mark.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transvaginal ablation of ovarian tissue under ultrasound guidance

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for ovulation occurrence and hormone levels

36 months

Regular visits up to 36 months

Crossover

Participants in the control arm may choose to crossover to the device arm after the 3-month follow-up visit

Post 3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• May Health System

Trial Overview The May Health System is being tested for its effectiveness in transvaginal ablation of ovarian tissue under ultrasound guidance in women with infertility related to Polycystic Ovary Syndrome (PCOS). This pivotal study randomly assigns participants to receive this intervention or a comparison treatment.

How Is the Trial Designed?

Group I: Device arm Experimental Treatment 1 Intervention

May Health procedure performed with the use of the May Health system intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to Polycystic Ovary Syndrome.

Group II: Control arm Active Control 1 Intervention

No fertility medication. Crossover participants who choose to crossover after the 3 month follow up visit will restart follow up as per the Device arm.

Who Is Running the Clinical Trial?

May Health

Lead Sponsor

Trials

3

Recruited

230+

Published Research Related to This Trial

Surgical options like laparoscopic ovarian drilling (LOD) and transvaginal hydrolaparoscopy (THL) can lead to over 50% of women with PCOS achieving spontaneous ovulation, making them effective for those resistant to medication.

More than 40% of patients who underwent surgery delivered babies, with LOD showing a higher delivery rate, although there were some risks such as ectopic pregnancies and miscarriages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There Still a Place for Surgery in Patients with PCOS? A Review. Della Corte, L., Boccia, D., Palumbo, M., et al.[2023]

Diet and lifestyle changes are the primary recommended treatments for polycystic ovary syndrome (PCOS), particularly for overweight women.

Recent studies suggest that metformin can effectively improve various symptoms of PCOS, indicating that Norwegian physicians should consider prescribing it for their patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of metformin in polycystic ovary syndrome]. Carlsen, SM.[2013]

In a study of 19 anovulatory women with clomiphene citrate-resistant PCOS, transvaginal ultrasound-guided ovarian interstitial laser treatment resulted in a high spontaneous ovulation rate of 84.2% within 6 months post-treatment.

The treatment significantly reduced serum levels of luteinizing hormone and testosterone, and led to a cumulative pregnancy rate of 32.3%, indicating its potential effectiveness in managing anovulation in PCOS without significant complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian interstitial YAG-laser: an effective new method to manage anovulation in women with polycystic ovary syndrome. Zhu, W., Li, X., Chen, X., et al.[2016]

Polycystic ovary syndrome (POS) can be treated with various methods, with progestogens as the minimal treatment and combined estrogen and progestogen therapy being fundamental for non-pregnant patients, especially to reduce hirsutism.

Anti-oestrogens and medications like dexamethasone and bromocriptine have shown promise in improving fertility and restoring ovulation, but treatment choices must be tailored to individual patient needs, considering factors like obesity and the desire for contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of the polycystic ovary syndrome (author's transl)]. Buvat, J., Buvat-Herbaut, M.[2006]

Polycystic ovary syndrome (PCOS) is a complex hormonal disorder that can lead to serious long-term health issues, including metabolic and cardiovascular problems, and is diagnosed based on specific criteria related to ovulation, androgen levels, and ovarian appearance.

Recent treatment options for PCOS focus not only on managing symptoms like irregular menstruation and infertility but also on addressing underlying issues such as insulin resistance and excess androgen levels, with medications like metformin and letrozole showing promise in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary medical therapy for polycystic ovary syndrome. Lanham, MS., Lebovic, DI., Domino, SE.[2016]

Polycystic ovary syndrome (PCOS) affects 8% to 13% of women of childbearing age and is associated with various health risks, including obesity and diabetes, making effective management crucial.

First-line treatments for women with PCOS who are not planning to conceive include lifestyle changes and combined oral contraceptives, which help manage symptoms like hyperandrogenism and provide endometrial protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contraception in the context of PCOS]. Spritzer, PM.[2022]

Polycystic ovary syndrome (PCOS) is a complex condition that affects reproductive and metabolic health in women, requiring regular screening and targeted lifestyle changes to manage weight and prevent complications.

For reproductive issues, first-line treatments include ovulation induction with antiestrogens like clomiphene citrate or letrozole, while combined oral contraceptives are recommended for managing menstrual irregularities and providing endometrial protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel strategies in the management of polycystic ovary syndrome. Spritzer, PM., Motta, AB., Sir-Petermann, T., et al.[2018]

A comprehensive core outcome set for studies on polycystic ovary syndrome (PCOS) was established, including 3 generic outcomes (BMI, quality of life, treatment satisfaction) and 30 specific outcomes across six domains: metabolic, reproductive, pregnancy, oncological, psychological, and long-term outcomes.

This core outcome set, developed with input from 71 health professionals and 123 women with lived experience of PCOS, aims to standardize reporting in PCOS research, improving the quality of studies and facilitating better evidence synthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmonising research outcomes for polycystic ovary syndrome: an international multi-stakeholder core outcome set. Al Wattar, BH., Teede, H., Garad, R., et al.[2021]

Laparoscopic ovarian drilling, performed using diathermy or laser, is an effective treatment for women with polycystic ovarian disease who are resistant to clomiphene citrate, leading to increased pregnancy rates.

In a study of 66 patients, the pregnancy rates after treatment were 23% for diathermy, 38% for laser, and 0% for wedge resection, indicating that the method of surgical intervention significantly impacts outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hope for clomiphene citrate resistant ovaries. Abdul Salam, MN., Hasanain, FH., Greiew, BK.[2013]

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. academic.oup.com academic.oup.com/humrep/article/40/Supplement_1/deaf097.127/8170588

O-127 The ULTRA trial: 12-month outcomes of transvaginal ... TVUS-guided ovarian ablation appears to be effective in inducing ovulation and generating pregnancies in PCOS-related anovulatory infertility ...

2. mayhealth.com mayhealth.com/healthcare-professionals/clinical-evidence/

Clinical Evidence These preliminary data suggest that the novel May Health TVUS-guided ovarian ablation System can be an effective method for restoring ovulation in women with ...

3. academic.oup.com academic.oup.com/humrep/article/doi/10.1093/humrep/deae108.1028/7703683

transvaginal ULTRAsound-guided ovarian ablation using May ... Laparoscopic ovarian drilling (LOD) is widely accepted as an effective second line treatment in PCOS-related infertility. However, laparoscopy ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06206746

NCT06206746 | The REBALANCE Study - a Prospective, ... The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under ...

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. 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 ...