Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome

NCT ID: NCT05320289

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2023-10-11

Brief Summary

The objective of the study is to provide preliminary evidence for the safety and effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

AblaCare Procedure

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.

Group Type: EXPERIMENTAL

AblaCare System

Intervention Type: DEVICE

The intervention includes the short-term use of the AblaCare System, which is comprised of three elements: (1) the AblaCare Needle-Catheter Ablation Device (NCAD) (the Device) a 16G echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secure onto a vaginal ultrasound probe; (2) the AblaCare Adapter which is clipped onto the ultrasound probe; and (3) the AblaCare Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use AblaCare NCAD for ovarian tissue ablation.

Once th patient is under conscious sedation, the physician guides the AblaCare system transvaginally with the use of a transvaginal ultrasound. Once the AblaCare device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.

Interventions

AblaCare System

The intervention includes the short-term use of the AblaCare System, which is comprised of three elements: (1) the AblaCare Needle-Catheter Ablation Device (NCAD) (the Device) a 16G echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secure onto a vaginal ultrasound probe; (2) the AblaCare Adapter which is clipped onto the ultrasound probe; and (3) the AblaCare Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use AblaCare NCAD for ovarian tissue ablation.

Once th patient is under conscious sedation, the physician guides the AblaCare system transvaginally with the use of a transvaginal ultrasound. Once the AblaCare device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age: ≥ 18 to ≤ 40 years

2. Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria: Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:

2.1. Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral follicle count per ovary ≥ 20) OR 2.2. Evidence of hyperandrogenaemia: either clinical (hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)

3. At least one ovary with ovarian volume ≥ 10ml

4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries

5. Failure to respond to first-line pharmacological treatment or is contraindicated for or decline such treatment.

6. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years

7. Willing to comply with Clinical Investigation Plan-specified follow-up evaluation

8. Ability to understand study requirements and has sufficient fluency in one of the IRB-approved written translation of the Patient Information and Informed consent form

9. Signed informed consent

10. Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL, total motility ≥ 40%, normal morphology ≥ 4%) within the last year

11. Ability to have regular vaginal intercourse during the study

12. No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed

Exclusion Criteria

1. Current pregnancy

2. Marked obesity, BMI > 40

3. Marked hyperandrogenism (FAI > 15)

4. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

5. Patient not willing to stop all concomitant first-line oral medications at least 6 weeks prior to study procedure and until the 3-month endpoint is reached, and all other forms of ovulation-induction treatment until the 6-month endpoint is reached

6. Lack of capacity to give informed consent

7. Lack of capacity to follow Clinical Investigation Plan and study requirements including all study follow-up visits

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

9. Patient with known or suspected periovarian adhesions

10. Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

May Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oklahoma

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

ULTRA-US

Identifier Type: -

Identifier Source: org_study_id