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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 : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
AblaCare

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : October 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.




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. Achievement of the desired number of ablations (assessed ahead of the procedure based on the ovarian volume of the patient and determined by the clinician) 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 ]
  2. AblaCare Procedure time [ 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 during procedure [ Time Frame: During procedure ]
  4. Technical ease of the procedure (usability): scale of 1(very easy) - 5 (impossible) [ Time Frame: During procedure ]
  5. 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 ]


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

Inclusion criteria for female participants:

  • Anovulatory infertility associated with Polycystic Ovary Syndrome (PCOS)
  • Age: ≥ 18 to ≤ 40 years
  • Diagnostic transvaginal ultrasound to validate ultrasonographic evidence of PCOS (multiple (⩾ 12) small (6-8mm) follicles, minimal ovarian volume of 10cm3) and where transducer is able to be brought into proximity of both ovaries
  • Biochemical evidence of PCOS: elevated LH (Luteinizing Hormone) /FSH (Follicle-Stimulating Hormone) ratio ≥ 2 and/or raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, androstenedione ≥ 10nmol/l, or FAI (Free Androgen Index) > 4)
  • Failed to respond to clomifene citrate treatment for up to 6 months prior to study enrollment
  • 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 (vasectomy, tubal ligation) that have been reversed

Exclusion criteria:

  • Current pregnancy
  • Marked obesity, BMI (Body Mass Index)> 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
  • Mental incapacity to give consent
  • Previous ovarian surgery: LOD (Laparoscopic Ovarian Drilling), endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.

Information from the National Library of Medicine

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
United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Kay Bowler    00441332788608    kayleigh.bowler1@nhs.net   
Contact: Lianne Hufton       lianne.hufton1@nhs.net   
Sponsors and Collaborators
AblaCare

Responsible Party: AblaCare
ClinicalTrials.gov Identifier: NCT03760926     History of Changes
Other Study ID Numbers: ULTRA
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
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

Keywords provided by AblaCare:
Anovulatory infertility

Additional relevant MeSH terms:
Syndrome
Infertility
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases