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

  • End date
    Mar 31, 2024
  • participants needed
  • sponsor
Updated on 4 October 2022
testosterone level
free androgen index


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.

Condition Polycystic Ovary Syndrome
Treatment AblaCare Kit
Clinical Study IdentifierNCT03760926
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Age: ≥ 18 to ≤ 40 years
Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as
1 Infertility associated with chronic anovulation or oligomenorrhea, defined
Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
as spontaneous intermenstrual periods of ≥35 days or a total of ≤9 menses per
year 2.2 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or
follicle number per ovary of ≥ 20) 2.3 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 the highest dose of first line pharmacological treatment
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%)
Candidates will be excluded from the study if ANY of the following conditions
Ability to have regular intercourse during the study
No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed
Marked obesity, BMI > 35
Marked hyperandrogenism (FAI > 15)
Pregnant, parturient or breastfeeding women
Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions
Subject with pacemaker, defibrillator or other active implant
Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note