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

Primary Purpose

Polycystic Ovary Syndrome, Infertility, Female

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AblaCare System
Sponsored by
May Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Polycystic Ovary Syndrome focused on measuring PCOS, Infertility related to PCOS, Ovulation restoration

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AblaCare Procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 18, 2022
Last Updated
February 6, 2023
Sponsor
May Health
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1. Study Identification

Unique Protocol Identification Number
NCT05320289
Brief Title
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome
Acronym
ULTRA-US
Official Title
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
May Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Infertility, Female
Keywords
PCOS, Infertility related to PCOS, Ovulation restoration

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AblaCare Procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AblaCare System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of at least one (1) ovulation between treatment and 3-month visit.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Time Frame
6 months
Title
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.
Time Frame
During procedure
Other Pre-specified Outcome Measures:
Title
Pain level after procedure completion measured by a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain)
Time Frame
Immediately after procedure completion, at 7-day and at 30-day follow up
Title
Pain medication taken during procedure and after procedure
Time Frame
During procedure, at 7-day and at 30-day follow up
Title
Documented ovulation
Time Frame
Between week 2 and week 24 post-procedure
Title
Documented pregnancy
Time Frame
Between week 2 and week 24 post-procedure, at any point during the study
Title
Menstruation occurrences
Time Frame
From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up
Title
Fertility treatment taken
Time Frame
Up to 12 months
Title
Intercourse activity frequency
Time Frame
At 7- and 30-day, 3-, 6-, 9- and 12-month follow up
Title
Number of ablations performed per ovary and estimated achieved ablation % of total ovary volume
Time Frame
At procedure
Title
Time required to complete procedure, defined as time from first insertion of the ultrasound probe and AblaCare NCAD to the completion of the final ablation
Time Frame
At procedure
Title
Device performance of the AblaCare System, defined as a successful completion of a full ovarian tissue ablation procedure without device deficiency related to one component of the AblaCare system
Time Frame
At procedure
Title
Ovarian volume in mL
Time Frame
At baseline, 3-week, 3-month and 6-month follow up
Title
Ovarian antral follicle count per ovary
Time Frame
At baseline, 3-week, 3-month and 6-month follow up
Title
Ovary morphology: either defined as PCOS or not
Time Frame
At baseline, 3-week, 3-month and 6-month follow up
Title
AMH in pmol/l
Time Frame
At baseline, 3-month and 6-month follow up
Title
Testosterone in nmol/l
Time Frame
At baseline, 3-month and 6-month follow up
Title
Androstenedione in nmol/l
Time Frame
At baseline, 3-month and 6-month follow up
Title
LH in IU/l
Time Frame
At baseline, 3-month and 6-month follow up
Title
FSH in IU/l
Time Frame
At baseline, 3-month and 6-month follow up
Title
Free Androgen Index calculated as the ratio of total Testosterone in nmol/l divided by SHBG in nmol/l and multiplied by 100
Time Frame
At baseline, 3-month and 6-month follow up
Title
Sex Hormone-Binding Globulin (SHBG) in nmol/l
Time Frame
At baseline, 3-month and 6-month follow up
Title
Menstrual cycle pattern reported as regular, oligomenorrhea or amenorrhea
Time Frame
From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up
Title
Hirsutism evaluation
Time Frame
At baseline, 3-month and 6-month follow up
Title
Acne evaluation
Time Frame
At baseline, 3-month and 6-month follow up
Title
BMI
Time Frame
At baseline, 3-month and 6-month follow up
Title
Quality of life measure by the health-related Quality-of-Life Questionnaire for Women with PCOS at baseline
Time Frame
At baseline, 3-month and 6-month follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: ≥ 18 to ≤ 40 years 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) At least one ovary with ovarian volume ≥ 10ml Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries Failure to respond to first-line pharmacological treatment or is contraindicated for or decline such treatment. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years Willing to comply with Clinical Investigation Plan-specified follow-up evaluation 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 Signed informed consent Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL, total motility ≥ 40%, normal morphology ≥ 4%) within the last year Ability to have regular vaginal intercourse during the study No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed Exclusion Criteria: Current pregnancy Marked obesity, BMI > 40 Marked hyperandrogenism (FAI > 15) Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study 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 Lack of capacity to give informed consent Lack of capacity to follow Clinical Investigation Plan and study requirements including all study follow-up visits Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery, ovarian cysts surgery Patient with known or suspected periovarian adhesions Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries
Facility Information:
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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