Infertility, Female, Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Infertility related to PCOS, Ovulation restoration
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.
Interventions
DEVICEAblaCare 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.
Sponsors
May Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of at least one (1) ovulation between treatment and 3-month visit. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Documented pregnancy | Between week 2 and week 24 post-procedure, at any point during the study |
| Menstruation occurrences | From 3-month prior to baseline examination, at 7-day, 30-day, 3-, 6-, 9-, and 12-month follow up |
| Fertility treatment taken | Up to 12 months |
| Intercourse activity frequency | At 7- and 30-day, 3-, 6-, 9- and 12-month follow up |
| Number of ablations performed per ovary and estimated achieved ablation % of total ovary volume | At procedure |
| 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 |
| 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 |
| Ovarian volume in mL | At baseline, 3-week, 3-month and 6-month follow up |
| Ovarian antral follicle count per ovary | At baseline, 3-week, 3-month and 6-month follow up |
| Ovary morphology: either defined as PCOS or not | At baseline, 3-week, 3-month and 6-month follow up |
| AMH in pmol/l | At baseline, 3-month and 6-month follow up |
| 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 |
| Androstenedione in nmol/l | At baseline, 3-month and 6-month follow up |
| LH in IU/l | At baseline, 3-month and 6-month follow up |
| FSH in IU/l | At baseline, 3-month and 6-month follow up |
| 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 |
| Sex Hormone-Binding Globulin (SHBG) in nmol/l | At baseline, 3-month and 6-month follow up |
| 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 |
| Hirsutism evaluation | At baseline, 3-month and 6-month follow up |
| Acne evaluation | At baseline, 3-month and 6-month follow up |
| BMI | At baseline, 3-month and 6-month follow up |
| 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 |
| Testosterone in nmol/l | At baseline, 3-month and 6-month follow up |
| Pain medication taken during procedure and after procedure | During procedure, at 7-day and at 30-day follow up |
| Documented ovulation | Between week 2 and week 24 post-procedure |
Countries
United States
Outcome results
None listed