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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Oocyte Retrieival and Post Operative Pain Control; Acupuncture

Treatments: Other: Sham acu-TENS; Other: Acu-TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06910540

2025.106

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women undergoing IVF-ET cycles are to be recruited from the Assisted Reproduction Technology unit in the Prince of Wales Hospital

Exclusion criteria

• Patient not eligible for acu-TENS
• Patient with severe cardiac and respiratory disease history
• Smoker or drinker
• Refuse or incompetence for informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups

Acu-TENS

Experimental group

Description:

Acu-TENS treatment

Treatment:

Other: Acu-TENS

Sham acu-TENS

Sham Comparator group

Description:

Sham acu-TENS without electric current

Treatment:

Other: Sham acu-TENS