ACU-TENS on Pain and Stress Reduction Before and During TUGOR

Objectives: To demonstrate the use of acupuncture-type transcutaneous electrical nerve stimulation (acu-TENS) during transvaginal ultrasound-guided oocyte retrieval (TUGOR) will reduce 50% of the intensity of pain experienced by women. Hypothesis to be tested: Does the use of acu-TENS reduce 50% of pain in TUGOR? Design and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology, Prince of Wales Hospital. 144 women undergoing TUGOR will be randomized to receive acu-TENS or sham acu-TENS for pain control during TUGOR. Study instruments: During the TUGOR procedure, ultrasound of the pelvis will be performed by Aloka ProSound SSD-3500SX device (Japan). Each follicle will be pierced using a single lumen ovum aspiration needle or a double lumen ovum aspiration catheter (COOK Medical, UK) under ultrasound guidance. Acu-TENS will be done using MTR+ Myolito Multifunctional Stimulator. Main outcome measures: Primary outcome is the pain score before and during TUGOR. Secondary outcomes include (1) other pain level parameters including pain control satisfaction, surgeon's assessment of the patient co-operation score and patient intraoperative pain; (2) stress and anxiety levels, Stait Trait Anxiety Inventory, General Health Questionnaire, Beck Depression Inventory, and saliva cortisol; (3) patient's satisfaction measured by Client Satisfaction Questionnaire and satisfaction score on pain control; (4) difficulty in retrieving oocytes; (5) IVF parameters; (6) safety profile; and (7) bias assessment. Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows. Expected results: The investigators expect that acu-TENS will reduce 50% of pain in TUGOR.

NCT Number	NCT06910540
Lead Sponsor	Chinese University of Hong Kong
Conditions	Oocyte Retrieival and Post Operative Pain Control, Acupuncture
Enrollment	144 participants
Start Date	2025-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-22