Clinical trial researchers at the First Affiliated Hospital of the Chinese People’s Liberation Army Naval Medical University announced a new study evaluating the analgesic effects of Transcutaneous Electrical Nerve Stimulation (TENS) based on Wrist-Ankle Acupuncture (WAA) theory when combined with Tramadol Hydrochloride during oocyte retrieval in IVF procedures. This surgical intervention addresses pain management challenges, prioritizing patient safety and procedural efficiency. Healthcare professionals, clinical teams, and medical device stakeholders should monitor updates from this trial.
- Addressing Pain in Oocyte Retrieval
- How Will the Study Be Conducted?
- What is TENS-WAA Technology?
- Frequently Asked Questions
- Implications of This Research
- Disclaimer
- Link to Full Study Information
Addressing Pain in Oocyte Retrieval
Oocyte retrieval is a common yet invasive step in in vitro fertilization (IVF), often accompanied by significant pain for patients. Effective pain management during this procedure is crucial for patient comfort and surgical success. The proposed Medical Device study introduces the novel use of TENS-WAA combined with Tramadol Hydrochloride to optimize pain relief during this procedure.
The investigational device leverages acupuncture principles applied transcutaneously via electrical stimulation, integrating them into a multimodal pain management framework. Clinical teams should assess this innovation’s potential role in surgical pain management strategies.
How Will the Study Be Conducted?
The trial, developed and sponsored by the First Affiliated Hospital of the Chinese PLA Naval Medical University, is still in the recruitment phase as of October 9, 2025. This randomized control study will evaluate the safety and performance of the TENS-WAA device in combination with Tramadol Hydrochloride during IVF-associated oocyte retrieval surgeries. It follows evidence-based regulatory and clinical protocols to ensure robust outcomes.
Patient eligibility criteria, device-specific considerations, and pain score metrics will be closely monitored. Researchers anticipate uncovering additional insights into non-invasive pain management strategies.
What is TENS-WAA Technology?
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory (TENS-WAA) is an innovative pain management device rooted in traditional acupuncture methods. Unlike other forms of acupuncture, TENS utilizes electrical impulses delivered to targeted areas, in this case, the wrist and ankle, to stimulate nerve pathways. The technology has the advantage of being non-invasive and adaptable to surgical contexts, such as oocyte retrieval.
The integration with Tramadol Hydrochloride supports synergistic pain reduction effects, potentially lowering reliance on higher dosages of systemic analgesics that carry associated risks.
Frequently Asked Questions
1. Is this study actively recruiting participants?
No, according to the announcement made on October 9, 2025, the trial is listed as not yet recruiting.
2. Which organization is leading this research?
The First Affiliated Hospital of the Chinese PLA Naval Medical University is overseeing the study.
3. What makes TENS-WAA different from other TENS devices?
TENS-WAA specifically applies electrical stimulation based on Wrist-Ankle Acupuncture theory, a traditional approach integrated into modern surgical pain management.
4. Can Tramadol Hydrochloride cause side effects?
Yes, like any opioid analgesic, Tramadol can cause side effects ranging from dizziness to nausea, but combining it with TENS-WAA may help reduce dosage needs.
Implications of This Research
Innovations in multimodal analgesics like TENS-WAA and Tramadol Hydrochloride have the potential to transform pain management in minimally invasive surgeries such as IVF oocyte retrieval. Clinical and regulatory stakeholders should follow this study closely as its findings could affect medical device development and patient care protocols. Updates on recruiting timelines and results will be critical for understanding its impact.
Disclaimer
This content is for informational purposes only and is not legal, regulatory, or medical advice. Medical device professionals should consult relevant guidance and standards for their practices.
Link to Full Study Information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07212127?term=medical+device