Clinical trial NCT03760926: A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility
Official title: ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Anovulatory infertility
Lead sponsor: May Health
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to provide preliminary evidence for the safety and effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.


Eligibility 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. Resistance to first-line pharmacological treatment, defined as at least 2 consecutive non-ovulatory cycles, including at least 1 cycle at the highest dose deemed clinically relevant for the patient
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)

Primary outcomes:
measure: 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
timeFrame: Up to 30 days
measure: 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.
timeFrame: During procedure
Secondary outcomes:
measure: Occurrence of ovulation following the procedure
timeFrame: Up to 3 months after procedure
Other outcomes:
measure: Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure
timeFrame: At procedure, 7 days, 30 days
measure: Usability of the May Health Kit
timeFrame: During procedure
measure: Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure
timeFrame: At 30 days
measure: May Health Procedure time
timeFrame: During procedure
measure: Occurrence of ovulation following the procedure
timeFrame: Up to 6 months after procedure
measure: Pregnancy
timeFrame: At 3, 6, 9 12 and 24 months
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: CU Saint-Luc
city: Le Kremlin-Bicêtre
country: France
facility: Bicetre Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Women Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Derby Royal Hospital
name: Saad Amer, MD, PhD
role: STUDY_DIRECTOR
References: