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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Infertility, Female
• Interventions: Device: AblaCare System

• Registration Number: NCT05320289
• Lead Sponsor: May Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-11
• Study Start: 2022-05-12
• Primary Completion: 2022-11-15
• Study Completion: 2023-10-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AblaCare Procedure	AblaCare System	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of at least one (1) ovulation between treatment and 3-month visit.	3 months

Secondary Outcome Measures

Name	Time	Method
Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.	During procedure
Occurrence of at least one (1) ovulation between treatment and the 6-month visit with or without 1st line medication 3 months or more post-procedure	6 months

Trial Locations

Locations (1)

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States