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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• the recruitment rate — The time frame for the recruitment rate is 12 months after the intervention begins.
  The recruitment rate refers to the number of eligible individuals screened.
• the enrollment rate — The time frame for the enrollment rate is 12 months after the intervention begins.
  The the enrollment rate refers to the proportion of eligible patients who consent to participate.
• the retention rate — The time frame for the retention rate spans from baseline to 4 weeks after ET.
  The retention rate refers to the proportion of enrolled individuals who do not withdraw from the intervention.
• the patient adherence — The time frame for patient adherence spans from baseline to 4 weeks after ET.
  The patient adherence refers to the proportion of patients who complete the intervention.

Trial sites (1)

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