First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Phase
Not applicable
Started
2025-11-08
Last updated
2025-10-08
Condition(s) studied
Oocyte Retrieval for IVFPain
Investigational drug(s) / intervention(s)
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)
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.
Study 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 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.
Eligibility
Sex
FEMALE
Min age
21 Years
Max age
42 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Primary outcome measure(s)
Pain VAS score — 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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Naval Medical University
Shanghai
Shanghai Municipality
More First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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