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

Polycystic Ovary Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320289
• Other study ID #: ULTRA-US
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: October 11, 2023

Study information

• Verified date: November 2023
• Source: May Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 11, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
May Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain level after procedure completion measured by a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain)		Immediately after procedure completion, at 7-day and at 30-day follow up
Other	Pain medication taken during procedure and after procedure		During procedure, at 7-day and at 30-day follow up
Other	Documented ovulation		Between week 2 and week 24 post-procedure
Other	Documented pregnancy		Between week 2 and week 24 post-procedure, at any point during the study
Other	Menstruation occurrences		From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up
Other	Fertility treatment taken		Up to 12 months
Other	Intercourse activity frequency		At 7- and 30-day, 3-, 6-, 9- and 12-month follow up
Other	Number of ablations performed per ovary and estimated achieved ablation % of total ovary volume		At procedure
Other	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		At procedure
Other	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		At procedure
Other	Ovarian volume in mL		At baseline, 3-week, 3-month and 6-month follow up
Other	Ovarian antral follicle count per ovary		At baseline, 3-week, 3-month and 6-month follow up
Other	Ovary morphology: either defined as PCOS or not		At baseline, 3-week, 3-month and 6-month follow up
Other	AMH in pmol/l		At baseline, 3-month and 6-month follow up
Other	Testosterone in nmol/l		At baseline, 3-month and 6-month follow up
Other	Androstenedione in nmol/l		At baseline, 3-month and 6-month follow up
Other	LH in IU/l		At baseline, 3-month and 6-month follow up
Other	FSH in IU/l		At baseline, 3-month and 6-month follow up
Other	Free Androgen Index calculated as the ratio of total Testosterone in nmol/l divided by SHBG in nmol/l and multiplied by 100		At baseline, 3-month and 6-month follow up
Other	Sex Hormone-Binding Globulin (SHBG) in nmol/l		At baseline, 3-month and 6-month follow up
Other	Menstrual cycle pattern reported as regular, oligomenorrhea or amenorrhea		From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up
Other	Hirsutism evaluation		At baseline, 3-month and 6-month follow up
Other	Acne evaluation		At baseline, 3-month and 6-month follow up
Other	BMI		At baseline, 3-month and 6-month follow up
Other	Quality of life measure by the health-related Quality-of-Life Questionnaire for Women with PCOS at baseline		At baseline, 3-month and 6-month follow up
Primary	Occurrence of at least one (1) ovulation between treatment and 3-month visit.		3 months
Secondary	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
Secondary	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