NCT06910540

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

Recruiting now NA Last updated 22 December 2025

What this trial tests

NA trial testing Acu-TENS in Oocyte Retrieival and Post Operative Pain Control in 144 participants. Currently enrolling.

Timeline

1 September 2025

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	144
Start date	1 September 2025
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• Acu-TENS
• Sham acu-TENS

Conditions studied

• Oocyte Retrieival and Post Operative Pain Control — all drugs for Oocyte Retrieival and Post Operative Pain Control →
• Acupuncture — all drugs for Acupuncture →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, female only, with Oocyte Retrieival and Post Operative Pain Control or Acupuncture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.