Prospective

CHEUNG WING CHING

office 4, 1 F
Department of OG,
Prince of Wales Hospital
30-32 Ngan Shing Street,
Shatin, N.T.
Hong Kong

2632 3199

cosycheung@cuhk.edu.hk

Department of O&G, CUHK

Hong Kong

Dr. CHUNG Pui Wah, Jacqueline

1F, Block F (specical Block)
Department of OG,
Prince of Wales Hospital
30-32 Ngan Shing Street,
Shatin, N.T.
Hong Kong

26321537

jacquelinechung@cuhk.edu.hk

Department of O&G, CUHK

Hong Kong

高能量聚焦式超音波（HIFU)治療無排卵性不孕的卵巢多囊症婦女之劑量研究

Yes

2016-10-19

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.515-T

Procedure

All sonographically guided HIFU procedures will be performed with the same HIFU system (HIFU-2001; SJTU Suntec Industry, Shanghai, China) that is equipped with an ultrasound device (Technos DU6; Esaote SpA, Genoa, Italy). The HIFU system is composed of 8 applicators arrayed on a round concave plate of 54 cm in diameter and 17 cm in focal length. Each transducer has an operating frequency of 1 ± 0.05 MHz. A 2.5–5.0-MHz convex diagnostic ultrasound probe mounted in the center to provide target localization, treatment planning, real-time monitoring during HIFU treatment, and imaging immediately after treatment. The HIFU applicators and the diagnostic ultrasound probe will be located at the bottom of a cylindrical chamber filled with degassed water and orientated in a perpendicularly upward direction. The system enables fine adjustment of the orientation of the HIFU applicators and the diagnostic ultrasound probe by 20° tilting from the perpendicular axis in all directions. The upper end of the water-filled generator chamber will be exposed and located at the middle of an elongated treatment table on which the patients will be positioned.

Oral maxolon (10mg), naproxen (500mg) and famotidine (20mg) will be given 1 hour before treatment for pain control. In those cases where pain relief was not well-controlled, additional intravenous fentanyl (50mcg) will be given when necessary. Hair over the skin of the lower abdomen will be shaved. Patients will be encouraged to have adequate fluid intake to ensure a full urinary bladder before treatment. The urinary bladder will not be catheterized. All HIFU procedures will be performed on an outpatient basis. The patients will be placed in a prone position with the lower abdominal surface submerged in the degassed water of the generator chamber. The entire treatment process will be performed under no anesthesia or sedation, which allows constant feedback from the patient. The patient will be instructed to give a constant feedback including a heat sensation score (4-point scale: 0, none; 1, mild; 2, moderate; and 3, severe) and a pain sensation score (11-point scale: 0, no pain; to 10, most severe pain). The HIFU power will be readjusted instantly when increased pain was reported during treatment to avoid skin burns.

This is not a drug trial

This is not a drug trial

This is not a drug trial

This is not a drug trial

There is no comparative treatments

This is not a drug trial

This is not a drug trial

This is not a drug trial

This is not a drug trial

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.

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

18

40

Female

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

This is not a drug trial

No