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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 : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
AblaCare

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Device: AblaCare Kit Not Applicable

Study Design
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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 : September 2021
Estimated Study Completion Date : September 2023

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Occurrence of ovulation following the procedure [ Time Frame: Up to 3 months after procedure ]

Other Outcome Measures:
  1. 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 ]
  2. Usability of the AblaCare Kit [ Time Frame: During procedure ]
  3. 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 ]
  4. AblaCare Procedure time [ Time Frame: During procedure ]
  5. Occurrence of ovulation following the procedure [ Time Frame: Up to 6 months after procedure ]
  6. Pregnancy [ Time Frame: At 3, 6, 9 12 and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Candidates for this study must meet ALL of the following criteria:

Inclusion criteria for female participants:

  1. Age: ≥ 18 to ≤ 40 years

  2. 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)

  3. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
  4. Failure of first-line pharmacological treatment defined as failure to ovulate on the highest dose of first line pharmacological treatment
  5. At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
  6. Willing to comply with protocol-specified follow-up evaluation

  7. Signed informed consent

    Couple inclusion criteria:

  8. Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL, motility A+B ⩾ 32%, normal forms ⩾ 4%).
  9. Ability to have regular intercourse during the study
  10. 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:

  1. Pregnant, parturient or breastfeeding women
  2. Marked obesity, BMI > 35
  3. Marked hyperandrogenism (FAI > 15)
  4. Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.
  5. Subject with pacemaker, defibrillator or other active implant
  6. Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
  7. 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)
Contacts and Locations
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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


Locations
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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      
Sponsors and Collaborators
AblaCare
More Information
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Responsible Party: AblaCare
ClinicalTrials.gov Identifier: NCT03760926    
Other Study ID Numbers: ULTRA
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AblaCare:
Anovulatory infertility
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases