NCT06742788

The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF

The Feasibility of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing in Vitro Fertilization: Study Protocol for a Pilot Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To assess the feasibility of taVNS on pregnancy outcomes of infertility subjects undergoing IVF, the primary aim of this trial will focus on encompassing recruitment, compliance, and preliminary engagement outcomes. The exploratory aim is to carry out clinical research, which entails evaluating the preliminary effects of the intervention in order to ascertain its potential benefits. The main question it aims to answer is: Does the taVNS is feasible and tolerated in the context of IVF? What medical problems do participants have when using the taVNS device? Researchers will compare the taVNS to the sham transcutaneous auricular vagus nerve stimulation (a look-alike device that produces a sub-threshold therapeutic stimulus and functions as a sham stimulus) and blank control to see if the taVNS device works to enhance outcomes of IVF. Participants will: Use the device a total of 1.5 hours daily, with the sessions divided into three parts, each lasting 30 minutes. At least one of these periods occur within 2 hours before bedtime. Visit the clinic according to the scheduled treatment time points of IVF. Keep a diary of their adverse events and the number of times they use the device.

Conditions

• Infertility Assisted Reproductive Technology

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is an emerging, non-invasive adjunctive therapy. The taVNS protocol is configured with a pulse width of 500 µs, a frequency of 25 Hz, and a current intensity titrated to each patient's pain tolerance threshold (range: 0.5-2.0 mA). The stimulation is to be carried out for a total of 1.5 hours daily, with the sessions divided into three parts, each lasting 30 minutes. At least one of these periods occur within 2 hours before bedtime. The study will use the Chinese National Institutes for Food and Drug Control certificated taVNS device TVNS-100 (Xinzhile Medical Technology Co., Jiangxi, China). The study includes an intervening period of 4 weeks.
DEVICE	sham transcutaneous auricular vagus nerve stimulation (staVNS)	The sham transcutaneous auricular vagus nerve stimulation (staVNS) serves as a sub-threshold therapeutic stimulus functions as a sham stimulus. The staVNS protocol is set at a pulse width of 500 µs and a frequency of 25 Hz, with an intensity value of 0.1 mA. The stimulation is to be carried out for a total of 1.5 hours daily, with the sessions divided into three parts, each lasting 30 minutes. At least one of these periods occur within 2 hours before bedtime. The study will use the Chinese National Institutes for Food and Drug Control certificated taVNS device TVNS-100 (Xinzhile Medical Technology Co., Jiangxi, China). The study includes an intervening period of 4 weeks.

Timeline

• Start date: 2025-03-04
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2024-12-19
• Last updated: 2025-07-02

Locations

1 site across 1 country: China