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ULTRA

A trial of the may health device in transvaginal ablation of ovarian tissue under ultrasound visualization in women with pcos infertility
Source : Import from center

clinicaltrials.gov reference: NCT03760926
Anovulatory infertility
Source : Import from center
Recruiment closed
Last modification : 2024/11/21
Study type

Interventional


Target population

Medical condition (targeted specialty)

Data not available

Participants profils

Participants gender(s)

FEMALE

Source : Import from center

Selection criterias

Inclusion 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)

Source : Import from center

Proposed Therapy or Intervention

Cohorts
May Health Procedure
Recruitment status
unknown
Current data since : November 21, 2024 19:00

Study description

Study 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.

Source : Import from center

Locations

Participating centers

    6 centers
  • BICETRE HOSPITAL

    Le kremlin-bicêtre

    VAL-DE-MARNE, FRANCE

    Local recruitment
    Recruiting status: CLOSED
  • CHU SAINT-PIERRE UNIVERSITY HOSPITAL

    Brussels

    BRUXELLES-CAPITALE, RÉGION DE, BELGIUM

    Local recruitment
    Recruiting status: CLOSED
  • CU SAINT-LUC/UZ ST-LUC

    Bruxelles - brussel

    BELGIUM

    Local recruitment
    Recruiting status: CLOSED
  • LIVERPOOL WOMEN HOSPITAL

    Liverpool

    UNITED KINGDOM

    Local recruitment
    Recruiting status: CLOSED
  • ROYAL DERBY HOSPITAL

    Derby

    UNITED KINGDOM

    Local recruitment
    Recruiting status: CLOSED
  • ROYAL HALLAMSHIRE HOSPITAL

    Sheffield

    ENGLAND, UNITED KINGDOM

    Local recruitment
    Recruiting status: CLOSED

Last modification : November 21, 2024
Current data since : 23 Nov 01:24
Data source : clinicaltrials.gov
clinicaltrials.gov reference: NCT03760926