Not Yet RecruitingNot Applicable

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

China60 participantsStarted 2025-11-08

Plain-language 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.

Who can participate

Age range

21 Years – 42 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 disor…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain VAS score

Timeframe: Within 3 minutes following oocyte retrieval

Trial details

NCT IDNCT07212127

SponsorFirst Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-08

Contact for this trial

Siyu Guo

+8618345293402 gsy1834529@163.com

View on ClinicalTrials.gov More Oocyte Retrieval for IVF trials