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

STATUS

Recruiting
End date

Mar 31, 2024
participants needed

30
sponsor

AblaCare

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Updated on 4 October 2022

See if I qualify

androgens

acne

testosterone

testosterone level

infertility

oligomenorrhea

anovulatory

hyperandrogenism

anovulation

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	Polycystic Ovary Syndrome
Treatment	AblaCare Kit
Clinical Study Identifier	NCT03760926
Sponsor	AblaCare
Last Modified on	4 October 2022

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Eligibility		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
	apply
	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)

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