Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery

NCT07212127 | Not Yet Recruiting DMC

• 1 other identifier: CHEC2025-347
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oocyte Retrieval for IVF; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 3 minutes following oocyte retrieval

Secondary Outcomes (3)

• Galvanic Skin Response

  during procedure

• Nausea Rating Scale

  30 minutes after oocyte retrieval

• Vomiting Rating Scale

  30 minutes after oocyte retrieval

Study Arms (2)

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.

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.

Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)

Interventions

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.

Electrical Stimulation Group; Sham electrical stimulation group

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Siyu Guo

CONTACT

+8618345293402; gsy1834529@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Before the trial begins, envelopes containing sequentially numbered cards from 1 to 60 will be prepared to determine participant allocation. The coordinator will open the envelopes in the order of participant enrollment. Throughout the trial, researchers are not allowed to alter the enrollment sequence. Participants will be informed in advance that they may experience electrical stimulation sensations, and communication between participants will be prohibited during the entire trial process. The statistician responsible for data analysis will remain blinded to the group allocation of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 8, 2025
• Study Start: November 8, 2025
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

CN (1)