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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Age: ≥ 18 to ≤ 40 years

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

‣ 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

Locations
United States
Oklahoma
University of Oklahoma
Oklahoma City
Time Frame
Start Date: 2022-05-12
Completion Date: 2023-10-11
Participants
Target number of participants: 5
Treatments
Experimental: 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.
Sponsors
Leads: May Health

This content was sourced from clinicaltrials.gov