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

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 4, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

December 30, 2025

Conditions
Infertility Assisted Reproductive Technology
Interventions
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.

Trial Locations (1)

710032

RECRUITING

Xijing Hospital, Xi'an

All Listed Sponsors
lead

Xijing Hospital

OTHER