Clinical trial NCT06910540: ACU-TENS on Pain and Stress Reduction Before and During TUGOR
Official title: Acupuncture-type Transcutaneous Electrical Nerve Stimulation on Pain and Stress Reduction Before and During Transvaginal Ultrasound-guided Oocyte Retrieval: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oocyte Retrieival and Post Operative Pain Control
Acupuncture
Keywords: Transvaginal ultrasound-guided oocyte retrieval
Acupuncture-type transcutaneous electrical nerve stimulation
Pain control
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain VAS (minimum 0 to maximum 100)
timeFrame: Before admission and 1 hour before TUGOR, when switch to contra-lateral ovary, shortly after TUGOR, and 30 minutes, 1 hour, 2 hours, and 4 hours after TUGOR
Secondary outcomes:
measure: Satisfaction score (minimum 0 to maximum 100)
timeFrame: 4 hour after TUGOR
measure: Patient compliance index (minimum 1 to maximum 5)
timeFrame: 4 hour after TUGOR
measure: Patient pain score (minimum 0 to maximum 4)
timeFrame: 4 hour after TUGOR
measure: Additional use of analgesia
timeFrame: 4 hour after TUGOR
measure: Spielberger's State Anxiety Inventory (minimum 20 to maximum 80)
timeFrame: Before admission and 1 hour after TUGOR
measure: 12-item General Health Questionnaire (minimum 12 to maximum 48)
timeFrame: Before admission.
measure: Beck Depression Inventory (minimum 0 to maximum 63)
timeFrame: Before admission.
measure: Saliva cortisol
timeFrame: Before admission and 1 hour after TUGOR
measure: Number of participants with treatment-related adverse events
timeFrame: Before admission.
Other outcomes:
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