Infertility, Female, Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Infertility related to PCOS, Ovulation restoration
Brief summary
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome
Detailed description
The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation 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
DEVICEMay Health System
The intervention includes the short-term use of the May Health System, which is comprised of three elements: (1) the May Health Needle-Catheter Ablation Device (NCAD) (the Device) a 16 gauge echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secured onto a vaginal ultrasound probe; (2) the May Health Adapter which is clipped onto the ultrasound probe; and (3) the May Health Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use May Health NCAD for ovarian tissue ablation. Once the patient is under conscious sedation, the physician guides the May Health system transvaginally with the use of a transvaginal ultrasound. Once the May Health 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
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Control arm has the option to crossover to receive the May Health procedure after completion of the 3 month primary endpoint visit.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 to ≤ 40 years 2. Infertility associated with oligo- or anovulation, AND EITHER: 2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR 2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modified Ferriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens, testosterone ≥ 2.5 nmol/L, or FAI \> 4) 3. At least one ovary with ovarian volume ≥ 10.0 mL and \< 28.0 mL 4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to at least one ovary. (Note: In the situation where only one ovary is appropriately sized according to the preceding criterion, then this requirement applies to the qualifying ovary.) 5. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years 6. Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment 7. Currently seeking immediate fertility 8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations 9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form 10. Signed informed consent
Exclusion criteria
1. Currently pregnant 2. BMI \> 40 3. Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL) 4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level \> 6.5% 5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc. 6. Active genital or urinary tract infection at the time of the procedure 7. Patient with known or suspected periovarian adhesions 8. Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary) 9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary 10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or a follicle, or functional cyst \>15 mm on transvaginal ultrasound in ovary to be treated 11. Received \> 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection) 12. Contraindicated to or known previous reaction to anesthesia or sedation regimen 13. Patient not willing to stop all concomitant first-line ovulation induction treatment (clomiphene citrate, letrozole, as well as metformin unless metformin is required for glycemic control) until the 3-month endpoint is reached 14. Male partner's total motile sperm count (TMSC) \< 10 million or not available (unless participant is planning donor sperm IUI) 15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study 16. Known or suspected gynecological malignancy 17. General health condition or systemic disease that may contribute to anovulation, infertility, or represent in the opinion of the investigator, a potential increased risk associated with the May Health system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation occurrence | 3 month follow-up | Occurrence of at least one (1) ovulation |
| Adverse event collection | Day 0 through 36 month visit | Adverse events will be collected between and at each study visit after randomization and throughout the duration of the study and analyzed for seriousness, severity, relatedness to the device and/or the procedure, and whether anticipated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative ovulation rate at 6 months without 1st-line medication | Device arm and Crossover at 6 month visit | Cumulative ovulation rate at 6 months, without 1st line medication restarted ≥ 3 months post-procedure |
| Cumulative ovulation rate at 6 months with 1st-line | Device arm and Crossover at 6 month visit | Cumulative ovulation rate at 6 months, with 1st line medication restarted ≥ 3 months post-procedure |
| Time to ovulation | Baseline for the control group is day of randomization to the date of first ovulation. Baseline for the treatment group is day of procedure to the date of first ovulation | Between baseline and 3-month follow-up with weekly assessment |
| Documented pregnancy | Control Arm, Device Arm, and Crossover group: from baseline to 30 Day, 3 Month; Device Arm and Crossover group only: 6 Month, 12 Month, 24 Month, 36 Month | Documented pregnancy at any point during the study (participant reported or medical record) |
| Hormone serum concentrations | Baseline through 36 month visit | Anti-Müllerian hormone (AMH) serum concentration (ng/mL); Androstenedione serum concentration (ng/dL); Sex Hormone Binding Globulin (SHBG) (nmol/L); Free Androgen Index (FAI) |
| Pain level after procedure | Device arm and Crossover - Baseline through 7 day visit | Measured by Visual Analog Scale (VAS) \[ranked from 0 (no pain) to 10 (worst pain)\], immediately after procedure completion, prior to discharge, 1-, and 7-day follow-up as well as baseline pain level reported by the participant during menstruation as reference |
| Performance of activities of daily living | Device arm and Crossover: baseline, 24 hours post procedure, D7 | Received score from activities of daily living (ADL) |
| Procedure times | Device arm and Crossover at Day 0 | Includes pre-treatment, treatment, and post-treatment |
| Time to discharge | Device arm and Crossover at Day 0 | Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU) |
| Modified Post Anaesthetic Discharge Scoring System (PADSS) | Device arm and Crossover at 1 hour, 2 hour post procedure | The Modified Post Anesthetic Discharge Scoring System (PADSS) score is completed after the procedure. The score evaluates whether the participant is safe to go home after anesthesia. It scores 0-2 points in each category (vital signs, activity, nausea/vomiting, pain, bleeding, intake/output), for a maximum score of 10. Discharge can occur with a score of 9 or more and a vital signs score of 2. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKarl Hansen, MD, PhD
Oklahoma University Health Sciences Center
PRINCIPAL_INVESTIGATORAnuja Dokras, MD, PhD
Penn Fertility Care
Outcome results
None listed