Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2025-11-30 -> 2027-11-30 2026-08-07
minor Completion pushed: 2025-12-30 -> 2027-12-30 2026-08-07
Trial Details
NCT Number NCT06742788
Lead Sponsor Xijing Hospital
Conditions Infertility Assisted Reproductive Technology
Enrollment 90 participants
Start Date 2025-03-04
Primary Completion 2027-11-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06