Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery
NCT ID: NCT07212127
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-11-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Electrical Stimulation Group
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.
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.
Sham electrical stimulation group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
21 Years
42 Years
FEMALE
No
Sponsors
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First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
OTHER
Responsible Party
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Xiaonan Huang
researcher
Locations
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The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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CHEC2025-347
Identifier Type: -
Identifier Source: org_study_id
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