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Lay 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.

Category

  • Womens Health
  • Reproductive Health
  • Wounds and Injuries
IRB Number
STUDY00000127
NCT Number
NCT # not yet entered

Eligibility

Eligible Ages
18-40
Eligible Genders
Females
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥ 18 to ≤ 40 years
  2. Infertility associated with oligo- or anovulation, AND EITHER:

    -Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20)

    OR 

     -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 neither ovary > 23.0 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 (FAI > 15)
  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 or tubal surgery such as ovarian drilling, endometriosis surgery, ovarian cysts surgery or sterilization procedure (i.e., tubal ligation)
  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 functional cyst >15 mm on transvaginal ultrasound
  11. Received > 2 cycles of treatment with gonadotropins without a resulting pregnancy
  12. Contraindicated to or known previous reaction to anesthesia or sedation regimen

Study Design

Arm Groups

Study Contact

Sally Kabro
210-567-3742
kabro@uthscsa.edu

Melissa Schwab
210-450-8817
schwabm1@uthscsa.edu

Marisa Fernandez
210-450-8016
fernandezm10@uthscsa.edu

Marisa Fernandez
210-450-8016
fernandezm10@uthscsa.edu

Principal Investigator
Randal Robinson