AblaCare System for Polycystic Ovary Syndrome

University of Oklahoma, Oklahoma City, OK
Targeting 2 different conditionsAblaCare SystemN/AWaitlist AvailableResearch Sponsored by May Health

Study Summary

This trial is testing a new system for transvaginal ablation of ovarian tissue in women with PCOS who have not responded to other treatments.

Eligible Conditions
  • Polycystic Ovary Syndrome
  • Female Infertility

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been diagnosed with Polycystic Ovary Syndrome (PCOS) based on certain symptoms, such as irregular periods or difficulty getting pregnant.
You are able to have regular sexual intercourse through the vagina during the study.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 3-week, 3-month and 6-month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 3-week, 3-month and 6-month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of at least one (1) ovulation between treatment and 3-month visit.
Secondary outcome measures
Occurrence of at least one (1) ovulation between treatment and the 6-month visit with or without 1st line medication 3 months or more post-procedure
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.
Other outcome measures
AMH in pmol/l
Acne evaluation
Androstenedione in nmol/l
+22 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AblaCare ProcedureExperimental Treatment1 Intervention
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.

Find a site

Who is running the clinical trial?

May HealthLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
30 Patients Enrolled for Polycystic Ovary Syndrome
AblaCareLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
30 Patients Enrolled for Polycystic Ovary Syndrome

Media Library

AblaCare System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05320289 — N/A
Polycystic Ovary Syndrome Research Study Groups: AblaCare Procedure
Polycystic Ovary Syndrome Clinical Trial 2023: AblaCare System Highlights & Side Effects. Trial Name: NCT05320289 — N/A
AblaCare System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05320289 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this experiment?

"Yes, the information on attests that this research effort is presently enrolling participants. The investigation was initially posted in May 12th 2022 and had its last update 5 weeks later on July 5th 2022. Five individuals are required to be recruited from a single medical center."

Answered by AI

Are there any vacancies left in the research program?

"Indeed, reports that recruitment for this study is still underway. It was first posted on May 12th 2022 and updated most recently on July 5th 2022. At the moment, the team behind it needs to find 5 participants from a single medical site."

Answered by AI

Does this research endeavor include individuals aged over fifty-five in its pool of subjects?

"This medical trial has set the age of eligibility at 18 to 40 years old. However, there are alternate trials for patients who do not meet this criteria; 401 studies catering to minors and 1019 for older people over 65."

Answered by AI

May I apply to participate in this research program?

"This medical trial is open to five sterile females between the ages of 18 and 40. For enrollment, individuals must fulfill a variety of prerequisites including: WHO 2010 parameters for sperm concentration (≥ 15 million/mL) and motility (≥ 40%), normal morphology (> 4%), ultrasonographic evidence or hyperandrogenaemia, ovarian volume ≥ 10ml, patency in at least one fallopian tube within three years prior to submission date, willingness to comply with study requirements as outlined by the Clinical Investigation Plan-specified follow-up evaluation, fluency in an IRB approved written language translation of the Patient Information and Informed"

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of Oklahoma
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Most responsive sites:
  1. University of Oklahoma: < 48 hours
Average response time
  • < 2 Days
~2 spots leftby Oct 2024