A Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility
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ClinicalTrials.gov Identifier: NCT03760926 |
Recruitment Status :
Recruiting
First Posted : December 3, 2018
Last Update Posted : July 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Device: AblaCare Kit | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS) |
Actual Study Start Date : | February 14, 2019 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | March 31, 2024 |

Arm | Intervention/treatment |
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Experimental: AblaCare Procedure
AblaCare Procedure performed with use of the AblaCare Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.
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Device: AblaCare Kit
The intervention consists in the realisation of the AblaCare Procedure using the AblaCare Kit, which comprises two elements: a disposable device (AblaCare Device) and a radiofrequency (RF) energy generator (AblaCare System). The AblaCare Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue. |
- Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications [ Time Frame: Up to 30 days ]
- Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization. [ Time Frame: During procedure ]
- Occurrence of ovulation following the procedure [ Time Frame: Up to 3 months after procedure ]
- Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure [ Time Frame: At procedure, 7 days, 30 days ]
- Usability of the AblaCare Kit [ Time Frame: During procedure ]
- Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure [ Time Frame: At 30 days ]
- AblaCare Procedure time [ Time Frame: During procedure ]
- Occurrence of ovulation following the procedure [ Time Frame: Up to 6 months after procedure ]
- Pregnancy [ Time Frame: At 3, 6, 9 12 and 24 months ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Candidates for this study must meet ALL of the following criteria:
Inclusion criteria for female participants:
- Age: ≥ 18 to ≤ 40 years
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Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as:
2.1 Infertility associated with chronic anovulation or oligomenorrhea, defined 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)
- Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
- 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
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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%).
- Ability to have regular intercourse during the study
- No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed
Candidates will be excluded from the study if ANY of the following conditions apply:
- Pregnant, parturient or breastfeeding women
- Marked obesity, BMI > 35
- Marked hyperandrogenism (FAI > 15)
- Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.
- Subject with pacemaker, defibrillator or other active implant
- 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 (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760926
Belgium | |
CHU Saint-Pierre | Recruiting |
Bruxelles, Belgium, 1000 | |
Contact: Study Coordinator +32 2 535 48 56 katty.renard@stpierre-bru.be | |
CU Saint-Luc | Recruiting |
Bruxelles, Belgium, 1200 | |
Contact: Study Coordinator +32 2 764 78 03 patricia.vanaken@uclouvain.be | |
France | |
Bicetre Hospital | Recruiting |
Le Kremlin-Bicêtre, France, 94270 | |
Contact: Study coordinator +330145217717 solene.fabre@aphp.fr | |
United Kingdom | |
Royal Derby Hospital | Recruiting |
Derby, United Kingdom, DE22 3NE | |
Contact: Study Coordinator +441332788664 | |
Royal Hallamshire Hospital | Recruiting |
Sheffield, United Kingdom, S10 2JF | |
Contact: Study Coordinator 00441142268050 |
Responsible Party: | AblaCare |
ClinicalTrials.gov Identifier: | NCT03760926 |
Other Study ID Numbers: |
ULTRA |
First Posted: | December 3, 2018 Key Record Dates |
Last Update Posted: | July 6, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anovulatory infertility |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |