Transvaginal Ablation for Polycystic Ovary Syndrome

Recruiting at 13 trial locations

Overseen By Laurel Stadtmauer, MD, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: May Health

Must not be taking: Anticoagulants, Ovulation inducers

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

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 data supports the effectiveness of the treatment for polycystic ovary syndrome?

Research shows that transvaginal ultrasound-guided ovarian interstitial laser treatment can help women with polycystic ovary syndrome who do not ovulate, especially those who do not respond to other treatments like clomiphene citrate. ^{1 2 3 4 5}

How is the transvaginal ablation treatment for PCOS different from other treatments?

Transvaginal ablation for PCOS is unique because it involves a minimally invasive surgical approach, unlike the more common medical treatments such as oral contraceptives or insulin-sensitizing drugs. This method may be considered for women who are resistant to drug therapy and aims to improve ovulation and pregnancy rates. ^{6 7 8 9 10}

Research Team

Karl Hansen, MD

Principal Investigator

Oklahoma University Health Sciences Center

Anuja Dokras, MD, PhD

Principal Investigator

Penn Fertility Care

Eligibility Criteria

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 am between 18 and 40 years old.

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

Exclusion Criteria

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

Contraindicated to or known previous reaction to anesthesia or sedation regimen

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

Trial Timeline

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

Treatment Details

Interventions

• May Health System (Procedure)

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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) 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Norway pubmed.ncbi.nlm.nih.gov

[Use of metformin in polycystic ovary syndrome]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Harmonising research outcomes for polycystic ovary syndrome: an international multi-stakeholder core outcome set. [2021]

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

Ovarian interstitial YAG-laser: an effective new method to manage anovulation in women with polycystic ovary syndrome. [2016]

5. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Hope for clomiphene citrate resistant ovaries. [2013]

6. France pubmed.ncbi.nlm.nih.gov

[Treatment of the polycystic ovary syndrome (author's transl)]. [2006]

7. France pubmed.ncbi.nlm.nih.gov

[Contraception in the context of PCOS]. [2022]

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

Contemporary medical therapy for polycystic ovary syndrome. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Is There Still a Place for Surgery in Patients with PCOS? A Review. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Novel strategies in the management of polycystic ovary syndrome. [2018]