Oocyte Retrieval for IVFNCT07212127
Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery
A study testing Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA) in people with Oocyte Retrieval for IVF and Pain, run by First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University at 1 site in China.
Trial summary
This study is a single-centre randomised controlled trial. It aimed to evaluate the efficacy and safety of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory(TENS-WAA) combined with tramadol hydrochloride for analgesia during transvaginal ultrasound-guided oocyte retrieval, by… Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Oocyte Retrieval for IVF, Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2025to 31 Dec 2026
- 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 21 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged between 21 and 42 years.
- Patients diagnosed with infertility requiring oocyte retrieval for in vitro fertilisation-embryo transfer.
- Body Mass Index (BMI) 18.5 ≤ BMI ≤ 29.9 kg/m².
- Regular menstrual cycles with ultrasound monitoring demonstrating dominant follicle development and ovulation during the natural cycle; good ovarian reserve: follicle-stimulating hormone (FSH) < 10 IU/L, antral follicle count (AFC) > 6, anti-Müllerian hormone (AMH) > 1.5 ng/ml.
- Undergoing ovarian stimulation therapy using follicle-stimulating hormone (FSH) or gonadotropin protocols.
- Electing tramadol hydrochloride injection for analgesia during oocyte retrieval.
- Voluntary participation with signed written informed consent.
Who cannot join
- History of other chronic pain conditions, or prolonged use of opioid medications, history of anaesthetic drug addiction, or chronic alcohol abuse.
- Severe pelvic adhesions.
- Presence of pacemakers or other implanted medical electronic devices.
- Concurrent use of high-frequency surgical equipment, artificial heart-lung machines, medical shortwave therapy, or microwave therapy devices.
- Presence of scarring or skin lesions at electrode application sites.
- Severe anxiety, depression, or other psychiatric conditions impairing accurate description of sensations, or any other disorders potentially affecting pain perception.
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- Conditions contraindicating or affecting oocyte retrieval, such as coagulation disorders, acute pelvic inflammation, vaginitis, trichomoniasis, endometriomas, ovarian cysts.
- Individuals with laparoscopically and/or ultrasonographically confirmed endometriosis.
- Patients with ovarian hyporesponsiveness following conventional ovarian stimulation medication.
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
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
Siyu Guo, +8618345293402, gsy1834529@163.com
gsy1834529@163.com
About this study
Official title: Analgesic Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture Theory Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery
This study is a single-centre randomised controlled trial. It aimed to evaluate the efficacy and safety of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory(TENS-WAA) combined with tramadol hydrochloride for analgesia during transvaginal ultrasound-guided oocyte retrieval, by comparing the analgesic effects and the prevention of postoperative nausea and vomiting between the TENS-WAA combined with tramadol hydrochloride group (experimental group) and the sham TENS-WAA combined with tramadol hydrochloride group (control group). Participants were randomly assigned to the experimental or control group. The experimental group received percutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory 30 minutes prior to the procedure, at a frequency of 2Hz with current intensity adjusted to the maximum tolerable level.Tramadol hydrochloride 100mg was administered intramuscularly 20 minutes before surgery. The control group received sham stimulation at the lowest intensity under identical conditions. The primary outcome measure was the Visual Analogue Scale (VAS). Secondary outcome measures included skin conductance response, postoperative nausea scale, and vomiting scale.
- Conditions
- Oocyte Retrieval for IVF, Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)Device
Based on the theory of wrist and ankle needles, transcutaneous electrical nerve stimulation is a kind of analgesic treatment device that combines wrist and ankle needles with transcutaneous electrical nerve stimulation, and can be worn on the human wrist and ankle. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture Theory uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle needle, which has the advantages of easy to wear, concentration of the treatment site, safety of the treatment, and no needles.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation Group | Experimental | According to the WAA theory, the selected Lower Zone 1 (LZ1) and Lower Zone 2 (LZ2) are defined as follows: LZ1 is located between the medial Achilles tendon and the medial malleolus, while LZ2 is positioned at the central inner edge of the ankle joint, near the posterior border of the tibia. Two electrode pads will be placed on each LZ1 and LZ2 of both legs, totaling eight electrode pads. The TENS-WAA device will be set to a frequency of 2 Hz, a pulse width of 500 μs, and a continuous waveform.The experimental group will receive transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory 30 minutes prior to oocyte retrieval surgery, with current intensity adjusted to the maximum tolerable level. Tramadol hydrochloride 100mg will be administered intramuscularly 20 minutes before surgery. Receives: Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA) |
| Sham electrical stimulation group | Placebo comparator | Participants in the control group will have the electrodes placed in the same positions as those in the stimulation group,with identical electrical stimulation frequency and pulse width settings.However,the control group received sham stimulation at the lowest intensity under identical conditions. Receives: Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS score
VAS is used to assess pain. It is widely used in clinical practice in China. The basic method is to use a 10-cm long floating ruler with 10 scale marks on one side, with 0 and 10 marks at the two ends. 0 means no pain, and 10 means the most severe pain that is unbearable.
Measured: Within 3 minutes following oocyte retrieval
Secondary outcomes (3)
Galvanic Skin Response
Galvanic Skin Response (GSR) is a bio-signal detection technique that reflects autonomic nervous system activity by measuring changes in skin conductance. Its core principle lies in the following: when an individual experiences emotional fluctuations, sympathetic nervous system excitation stimulates increased secretion from eccrine sweat glands. The electrolytes in sweat significantly alter the conductive properties of the skin surface, and these transient changes in conductance form the characteristic spikes of the GSR signal.
Measured: during procedure
Nausea Rating Scale
The Nausea Assessment Scale is divided into four scores: 0 points (None) indicates no nausea sensation; 1 point (Mild) indicates a feeling of wanting to vomit but without muscle contractions; 2 points (Moderate) indicates spasmodic contractions of the diaphragm and chest/abdominal muscles but without expulsion of gastric contents; 3 points (Severe) indicates frequent muscle contractions with expulsion of gastric contents.
Measured: 30 minutes after oocyte retrieval
Vomiting Rating Scale
The Vomiting Assessment Scale is divided into four scores: 0 points (None) indicates no vomiting; 1 point (Mild) indicates vomiting 1-2 times; 2 points (Moderate) indicates vomiting 3-4 times; 3 points (Severe) indicates vomiting more than 5 times with expulsion of large amounts of gastric contents.
Measured: 30 minutes after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start8 Nov 2025 (estimated)
- Primary completion8 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte Retrieval for IVFStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaonan Huang, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212127
- Sponsor's protocol ID
- CHEC2025-347
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture Theory Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery
- ClinicalTrials.gov ID
- NCT07212127
- Acronym / sponsor ID
- CHEC2025-347
- Conditions
- Oocyte Retrieval for IVF, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical UniversityUniversity, hospital or other
- Study start
- 8 Nov 2025 (estimated)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 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.
This study is a single-centre randomised controlled trial. It aimed to evaluate the efficacy and safety of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory(TENS-WAA) combined with tramadol hydrochloride for analgesia during transvaginal ultrasound-guided oocyte retrieval, by comparing the analgesic effects and the prevention of postoperative nausea and vomiting between the TENS-WAA combined with tramadol hydrochloride group (experimental group) and the sham TENS-WAA combined with tramadol hydrochloride group (control group). Participants were randomly assigned to the experimental or control group. The experimental group received percutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory 30 minutes prior to the procedure, at a frequency of 2Hz with current intensity adjusted to the maximum tolerable level.Tramadol hydrochloride 100mg was administered intramuscularly 20 minutes before surgery. The control group received sham stimulation at the lowest intensity under identical conditions. The primary outcome measure was the Visual Analogue Scale (VAS). Secondary outcome measures included skin conductance response, postoperative nausea scale, and vomiting scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)According to the WAA theory, the selected Lower Zone 1 (LZ1) and Lower Zone 2 (LZ2) are defined as follows: LZ1 is located between the medial Achilles tendon and the medial malleolus, while LZ2 is positioned at the central inner edge of the ankle joint, near the posterior border of the tibia. Two electrode pads will be placed on each LZ1 and LZ2 of both legs, totaling eight electrode pads. The TENS-WAA device will be set to a frequency of 2 Hz, a pulse width of 500 μs, and a continuous waveform.The experimental group will receive transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory 30 minutes prior to oocyte retrieval surgery, with current intensity adjusted to the maximum tolerable level. Tramadol hydrochloride 100mg will be administered intramuscularly 20 minutes before surgery. |
| Sham electrical stimulation group | Placebo comparator | Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)Participants in the control group will have the electrodes placed in the same positions as those in the stimulation group,with identical electrical stimulation frequency and pulse width settings.However,the control group received sham stimulation at the lowest intensity under identical conditions. |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females aged between 21 and 42 years.
- Patients diagnosed with infertility requiring oocyte retrieval for in vitro fertilisation-embryo transfer.
- Body Mass Index (BMI) 18.5 ≤ BMI ≤ 29.9 kg/m².
- Regular menstrual cycles with ultrasound monitoring demonstrating dominant follicle development and ovulation during the natural cycle; good ovarian reserve: follicle-stimulating hormone (FSH) < 10 IU/L, antral follicle count (AFC) > 6, anti-Müllerian hormone (AMH) > 1.5 ng/ml.
- Undergoing ovarian stimulation therapy using follicle-stimulating hormone (FSH) or gonadotropin protocols.
Key exclusion criteria (9 listed)
- History of other chronic pain conditions, or prolonged use of opioid medications, history of anaesthetic drug addiction, or chronic alcohol abuse.
- Severe pelvic adhesions.
- Presence of pacemakers or other implanted medical electronic devices.
- Concurrent use of high-frequency surgical equipment, artificial heart-lung machines, medical shortwave therapy, or microwave therapy devices.
- Presence of scarring or skin lesions at electrode application sites.
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)Based on the theory of wrist and ankle needles, transcutaneous electrical nerve stimulation is a kind of analgesic treatment device that combines wrist and ankle needles with transcutaneous electrical nerve stimulation, and can be worn on the human wrist and ankle. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture Theory uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle needle, which has the advantages of easy to wear, concentration of the treatment site, safety of the treatment, and no needles. | Device | Electrical Stimulation Group, Sham electrical stimulation group |
Primary outcome
Pain VAS score
Time frame: Within 3 minutes following oocyte retrieval
VAS is used to assess pain. It is widely used in clinical practice in China. The basic method is to use a 10-cm long floating ruler with 10 scale marks on one side, with 0 and 10 marks at the two ends. 0 means no pain, and 10 means the most severe pain that is unbearable.
3 secondary outcomes
Galvanic Skin Response
Time frame: during procedure
Nausea Rating Scale
Time frame: 30 minutes after oocyte retrieval
Vomiting Rating Scale
Time frame: 30 minutes after oocyte retrieval
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 8 Oct 2025.
- Individual participant dataSharing planned: Yes
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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 Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA) in people with Oocyte Retrieval for IVF and Pain, run by First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Oct 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 Siyu Guo (+8618345293402, gsy1834529@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS score (time frame: Within 3 minutes following oocyte retrieval). 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 8 Oct 2025.