Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06910540

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

Led by Chinese University of Hong Kong · Updated on 2025-12-22

144

Participants Needed

1

Research Sites

173 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing IVF-ET cycles recruited from the Assisted Reproduction Technology unit at Prince of Wales Hospital
Not Eligible

You will not qualify if you...

  • Not eligible for acu-TENS treatment
  • History of severe cardiac or respiratory disease
  • Current smoker or drinker
  • Unable or unwilling to give informed consent

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Trial Site Locations

Total: 1 location

1

Chung Pui Wah, Jacqueline

Hong Kong, China

Actively Recruiting

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Research Team

P

Pui Wah Jacqueline Chung

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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