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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| May Health Procedure | Experimental | May Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| May Health Kit | Device | The intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 30 days | |
| 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. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ovulation following the procedure | Up to 3 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure | At procedure, 7 days, 30 days | |
| Usability of the May Health Kit | During procedure |
Candidates for this study must meet ALL of the following criteria:
Inclusion criteria for female participants:
Age: ℠18 to †40 years
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 â„35 days or a total of â€9 menses per year 2.2 Ultrasonographic evidence of PCOS (ovarian volume â„ 10ml and/or follicle number per ovary of â„ 20) 2.3 Evidence of hyperandrogenaemia: either clinical (hirsutism or acne) or biochemical (raised serum concentration of androgens (testosterone â„ 2.5nmol/l, or FAI > 4)
Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
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
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%).
Ability to have regular intercourse during the study
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:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Amer, MD, PhD | Derby Royal Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Pierre | Brussels | 1000 | Belgium | |||
| CU Saint-Luc |
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| Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure | At 30 days |
| May Health Procedure time | During procedure |
| Occurrence of ovulation following the procedure | Up to 6 months after procedure |
| Pregnancy | At 3, 6, 9 12 and 24 months |
| Brussels |
| 1200 |
| Belgium |
| Bicetre Hospital | Le Kremlin-BicĂȘtre | 94270 | France |
| Royal Derby Hospital | Derby | DE22 3NE | United Kingdom |
| Liverpool Women Hospital | Liverpool | L8 7SS | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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