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

NCT06742788 | Recruiting DMC

• 1 other identifier: KY20242351liuyonghong
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infertility; Assisted Reproductive Techniques; Transcutaneous Auricular Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (4)

• the recruitment rate

  The recruitment rate refers to the number of eligible individuals screened.

  The time frame for the recruitment rate is 12 months after the intervention begins.

• the enrollment rate

  The the enrollment rate refers to the proportion of eligible patients who consent to participate.

  The time frame for the enrollment rate is 12 months after the intervention begins.

• the retention rate

  The retention rate refers to the proportion of enrolled individuals who do not withdraw from the intervention.

  The time frame for the retention rate spans from baseline to 4 weeks after ET.

• the patient adherence

  The patient adherence refers to the proportion of patients who complete the intervention.

  The time frame for patient adherence spans from baseline to 4 weeks after ET.

Secondary Outcomes (8)

• the total number of oocytes retrieved

  On the day of oocyte retrieval

• high-quality embryo rate

  On the day of embryo transfer (day 14)

• the positive rate of hCG

  The positive rate of hCG will also be observed two weeks after ET

• Clinical Pregnancy Rate

  The primary efficacy outcome of the study is to measure and compare the difference in CPR among three groups 4 weeks after ET.

• The Fertility Quality of Life Scale (FertiQoL, Simplified Chinese version)

  The scale will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.

Study Arms (3)

the taVNS group

EXPERIMENTAL

The taVNS group receives Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) along with In Vitro Fertilization (IVF) treatment. 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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

the staVNS group

SHAM COMPARATOR

The staVNS group receives sham transcutaneous auricular vagus nerve stimulation, along with In Vitro Fertilization (IVF) treatment. 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 of 0.1 mA acts as a therapeutic signal below the threshold level and functions as a sham stimulus. 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.

Device: sham transcutaneous auricular vagus nerve stimulation (staVNS)

the IVF control group

NO INTERVENTION

The IVF control group refers to receiving only in vitro fertilization (IVF) treatment without any additional Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) treatment.

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) DEVICE

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.

the taVNS group

sham transcutaneous auricular vagus nerve stimulation (staVNS) DEVICE

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.

the staVNS group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 20 to 40 years, diagnosed with infertility, and preparing to undergo IVF treatment;
• Female subjects with anti-Müllerian hormone (AMH) \> 1.2 ng/mL;
• Scoring at mild-to-moderate levels of impairment on anxiety, and depression scales;
• Both the subject and their family sign the informed consent form.

You may not qualify if:

• The subject had been treated with taVNS in the past;
• Subjects preparing to undergo frozen embryo transfer;
• Subjects with a history of mental disorder or who score at a severe level of impairment on anxiety and depression scales;
• Taking sedatives, anxiety, depression, or psychiatric medications;
• Comorbidities including arrhythmia, hypertension, diabetes, chronic heart and kidney diseases;
• Ineligibility for enrollment assessed by a gynecologist or neurologist;
• Metallic implants or devices contraindicating taVNS.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Yonghong Liu

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofei Fei

CONTACT

+8613822311264; feixiaofeixzyz@126.com

Yonghong Liu

CONTACT

+8629-84771377; liuyhong@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Neurology

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 19, 2024
• Study Start: March 4, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)