A Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    30
  • sponsor
    AblaCare
Updated on 16 June 2021
androgens
acne
testosterone
testosterone level
infertility
anovulatory
hyperandrogenism
free androgen index
hirsutism

Summary

The objective of this study is to provide preliminary evidence for the safety and effectiveness of the AblaCare Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

Details
Condition OVARIAN CYST, Polycystic Ovary Syndrome, Ovarian Cysts, Polycystic Ovarian Syndrome, pcos, polycystic ovary disease
Treatment AblaCare Kit
Clinical Study IdentifierNCT03760926
SponsorAblaCare
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Anovulatory infertility associated with PCOS
Age: 18 to 40 years
Diagnostic transvaginal ultrasound to validate ultrasonographic evidence of PCOS (ovarian volume 10ml and/or follicle number per ovary of 20)
Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
Evidence of hyperandrogenaemia: either clinical (hirsutism or acne) or biochemical (raised serum concentration of androgens (testosterone 2.5nmol/l, or FAI > 4)
Failure of first-line pharmacological treatment defined as
failure to ovulate on highest dose of first line pharmacological treatment, OR
failure to conceive on appropriate dose of first line pharmacological treatment for at least six cycles, OR
discontinuation of first-line pharmacological treatment due to side-effects
At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
Willing to comply with protocol-specified follow-up evaluation
Signed informed consent
Couple inclusion criteria
Normal sperm parameters based on WHO 2000 criteria (concentration 15 million/mL, motility A+B 32%, normal forms 4%)
No previous sterilization procedures
Candidates will be excluded from the study if ANY of the following conditions
apply
Current pregnancy
Marked obesity, BMI > 35
Marked hyperandrogenism (FAI > 15)
Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
Lack of capacity to give informed consent
Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions
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