polycystic ovarian syndrome
Conditions
Interventions
Case series:All sonographically guided HIFU procedures will be performed with the same HIFU system (HIFU-2001
SJTU Suntec Industry, Shanghai, China)
Sponsors
Prince of Wales Hospital, The Chinese University of Hong Kong
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Premenopausal women aged 18 to 40 years diagnosed with PCOS with anovulatory infertility; 2. Ability to give informed consent; 3. Body mass index <30 kg/m2; 4. Not on hormonal therapy (GnRH or combined oral contraceptive pills - COC) at the time of HIFU treatment; 5. No previous history of laparoscopic ovarian drilling or ovarian surgery; 6. Women with patent bilateral tubes; 7. Failure to achieve ovulation or pregnancy with incremental doses of clomiphene citrate; 8. Ability to give communicate clearly with a nurse or physician during HIFU treatment; 9. Women willing and able to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Pre-existing thyroid problem or hyperprolactinaemia which may cause anovulation; 2. Those with pre-existing compromised ovarian failure as evident by day 2 FSH >10IU/L or an AMH value of <0.75ng/ml before the treatment; 3. Pregnant or lactating; 4. Presence of active pelvic inflammatory disease, genital or extra-genital malignancy; 5. Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU; 6. Unable to give consent or those who are unable for regular follow- ups after the study; 7. Those with an intrauterine device in situ; 8. Those with tattoos or metalic implants over their abdomen; 9. Male partner with moderate to severe male factor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prospectively evaluate the feasibility and efficacy of HIFU in inducing ovulation in PCOS women.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the acute, medium-term and long-term endocrine changes after HIFU and compare the changes to those reported after LOD.;To determine the lowest effective dose of ultrasound energy used during HIFU in the induction of ovulation in women with PCOS.;To determine the safety of HIFU in the treatment of PCOS, including the possible risk of compromised ovarian function.; | — |
Countries
China
Contacts
Public ContactDr. CHUNG Pui Wah, Jacqueline
Department of O&G, CUHK
Outcome results
None listed