Oocyte Retrieival and Post Operative Pain ControlNCT06910540
ACU-TENS on Pain and Stress Reduction Before and During TUGOR
A study testing Acu-TENS in people with Oocyte Retrieival and Post Operative Pain Control and Acupuncture, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oocyte Retrieival and Post Operative Pain Control, Acupuncture
- What is being tested?
- Acu-TENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing IVF-ET cycles are to be recruited from the Assisted Reproduction Technology unit in the Prince of Wales Hospital
Who cannot join
- Patient not eligible for acu-TENS
- Patient with severe cardiac and respiratory disease history
- Smoker or drinker
- Refuse or incompetence for informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chung Pui Wah, Jacqueline
Hong Kong
Chung PW Jacqueline, 35053489, jacquelinechung@cuhk.edu.hk
About this study
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
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.
Read more
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.
- Being tested
- Acu-TENS, Sham acu-TENS
- Keywords
- Transvaginal ultrasound-guided oocyte retrieval, Acupuncture-type transcutaneous electrical nerve stimulation, Pain control
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acu-TENSOther
This protocol makes use of the acu-TENS treatment on the acupoints Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6), and Taichong (LR3). After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTR+ Myolito Multifunctional Stimulator MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. A pulse rate of 120 Hz, current of 3-5 mA, and pulse width of 300µS will be delivered continually during TUGOR.
Sham acu-TENSOther
In the sham acu-TENS, within the same time interval, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current.
| Study group | Role | What they receive |
|---|---|---|
| Acu-TENS | Experimental | Acu-TENS treatment Receives: Other: Acu-TENS |
| Sham acu-TENS | Sham comparator | Sham acu-TENS without electric current Receives: Other: Sham acu-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS (minimum 0 to maximum 100)
Research assistance who is not involved in the TUGOR will ask patients about the pain level by a ruler on 100mm visual analogous scale (VAS; 0 mm = no pain, 100mm = worst pain). Before operation, patient will be asked to give VAS pain and anxiety before admission and 1 hour before TUGOR. This is to assess the baseline pain perception for the patients. VAS for vaginal and abdominal pain and will be rated by patient when the surgeon switch to contra-lateral ovary and shortly after TUGOR. Patient will be asked to rate the abdominal and vaginal pain again 30 minutes, 1 hour, 2 hours, and 4 hours after TUGOR (before discharge). With a change of more than or equal to 10 for the 100 mm VAS, the analgesic intervention is clinical important.
Measured: 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 (9)
Satisfaction score (minimum 0 to maximum 100)
Patient will be asked to give the satisfaction score regarding the pain control of TUGOR: excellent, satisfactory, fair and unsatisfactory. For those patients had undergone previous oocyte retrieval by conscious sedation alone, they will ask whether they prefer the present treatment modality or not.
Measured: 4 hour after TUGOR
Patient compliance index (minimum 1 to maximum 5)
To validate the VAS pain score rated by patients, surgeons will rate the patient compliance index. For the patient compliance index, it is a 5-point Likert scale rated from 1 (fully co-operation) to 5 (no co-operation, procedure abandoned).
Measured: 4 hour after TUGOR
Patient pain score (minimum 0 to maximum 4)
To validate the VAS pain score rated by patients, surgeons will rate the patient pain score. For the patient pain score, it is a 5-point Likert scale rated from 0 (patient did not show any sign of pain) to 4 (patient did not let the procedure continue which was demonstrated by verbal or bodily expression).
Measured: 4 hour after TUGOR
Additional use of analgesia
The additional of analgesic during and after TUGOR will be recorded.
Measured: 4 hour after TUGOR
Spielberger's State Anxiety Inventory (minimum 20 to maximum 80)
Basal anxiety level will be assessed by the Spielberger's State Anxiety Inventory (STAI; both the S-AD questionnaire for stress level and T-AI questionnaire for traits). As stress state may affect the pain level, S-AD questionnaire will be done again after TUGOR.
Measured: Before admission and 1 hour after TUGOR
12-item General Health Questionnaire (minimum 12 to maximum 48)
Basal anxiety level will be assessed by the 12-item General Health Questionnaire (GHQ-12).
Measured: Before admission.
Beck Depression Inventory (minimum 0 to maximum 63)
Basal anxiety level will be assessed by the Beck Depression Inventory (BDI).
Measured: Before admission.
Saliva cortisol
Saliva cortisol would be utilized as an objective indicator of our patient's stress level while undergoing TUGOR. Saliva cortisol will be measured before and immediately after TUGOR procedures.
Measured: Before admission and 1 hour after TUGOR
Number of participants with treatment-related adverse events
Patients will be invited to try on the TENS pads to see if they are allergic to it. This will be assessed by observing if their skin may become red and irritated.
Any treatment-related dizziness, headache, tiredness will be recorded
Measured: Before admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte Retrieival and Post Operative Pain ControlStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910540
- Sponsor's protocol ID
- 2025.106
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06910540
- Acronym / sponsor ID
- 2025.106
- Keywords
- Transvaginal ultrasound-guided oocyte retrieval, Acupuncture-type transcutaneous electrical nerve stimulation, Pain control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acu-TENS | Experimental | Other: Acu-TENSAcu-TENS treatment |
| Sham acu-TENS | Sham comparator | Other: Sham acu-TENSSham acu-TENS without electric current |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing IVF-ET cycles are to be recruited from the Assisted Reproduction Technology unit in the Prince of Wales Hospital
Key exclusion criteria (4 listed)
- Patient not eligible for acu-TENS
- Patient with severe cardiac and respiratory disease history
- Smoker or drinker
- Refuse or incompetence for informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acu-TENSThis protocol makes use of the acu-TENS treatment on the acupoints Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6), and Taichong (LR3). After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTR+ Myolito Multifunctional Stimulator MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. A pulse rate of 120 Hz, current of 3-5 mA, and pulse width of 300µS will be delivered continually during TUGOR. | Other | Acu-TENS |
| Sham acu-TENSIn the sham acu-TENS, within the same time interval, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current. | Other | Sham acu-TENS |
Primary outcome
Pain VAS (minimum 0 to maximum 100)
Time frame: 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
Research assistance who is not involved in the TUGOR will ask patients about the pain level by a ruler on 100mm visual analogous scale (VAS; 0 mm = no pain, 100mm = worst pain). Before operation, patient will be asked to give VAS pain and anxiety before admission and 1 hour before TUGOR. This is to assess the baseline pain perception for the patients. VAS for vaginal and abdominal pain and will be rated by patient when the surgeon switch to contra-lateral ovary and shortly after TUGOR. Patient will be asked to rate the abdominal and vaginal pain again 30 minutes, 1 hour, 2 hours, and 4 hours after TUGOR (before discharge). With a change of more than or equal to 10 for the 100 mm VAS, the analgesic intervention is clinical important.
9 secondary outcomes
Satisfaction score (minimum 0 to maximum 100)
Time frame: 4 hour after TUGOR
Patient compliance index (minimum 1 to maximum 5)
Time frame: 4 hour after TUGOR
Patient pain score (minimum 0 to maximum 4)
Time frame: 4 hour after TUGOR
Additional use of analgesia
Time frame: 4 hour after TUGOR
Spielberger's State Anxiety Inventory (minimum 20 to maximum 80)
Time frame: Before admission and 1 hour after TUGOR
12-item General Health Questionnaire (minimum 12 to maximum 48)
Time frame: Before admission.
Beck Depression Inventory (minimum 0 to maximum 63)
Time frame: Before admission.
Saliva cortisol
Time frame: Before admission and 1 hour after TUGOR
Number of participants with treatment-related adverse events
Time frame: Before admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acu-TENS in people with Oocyte Retrieival and Post Operative Pain Control and Acupuncture, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pui Wah Jacqueline Chung (+852 3505 1537, jacquelinechung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS (minimum 0 to maximum 100) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.