The Feasibility of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing In Vitro Fertilization: Pilot Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) on pregnancy outcomes in women diagnosed with infertility undergoing in vitro fertilization (IVF). This pilot randomized controlled trial aims to assess recruitment, compliance, and patient engagement with the taVNS device, while also exploring potential preliminary effects on IVF success rates and related clinical outcomes. The trial compares taVNS with sham stimulation and a control group to understand if taVNS is tolerated and feasible in this context. Participants are randomly assigned to one of three groups: the taVNS group receiving active device stimulation, the sham taVNS group receiving a sub-threshold placebo-like stimulation, or the IVF control group receiving only standard IVF treatment. The active and sham taVNS protocols involve daily stimulation totaling 1.5 hours, split into three 30-minute sessions, with at least one session occurring within two hours before bedtime. The intervention period lasts for 4 weeks, using a certified taVNS device. During the study, participants visit the clinic according to their IVF treatment schedule and keep diaries to record any adverse events and device usage. Researchers monitor recruitment, enrollment, retention, and adherence rates over 12 months and up to 4 weeks after embryo transfer. They also measure clinical outcomes including number of oocytes retrieved, embryo quality, pregnancy rates, and patient-reported quality of life, sleep quality, anxiety, and depression at baseline, embryo transfer, and two weeks after transfer.

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