Clinical trial NCT05320289: Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Infertility, Female
Keywords: PCOS
Infertility related to PCOS
Ovulation restoration
Lead sponsor: May Health
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

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