Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing In Vitro Fertilization

Last updated: April 1, 2025
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

sham transcutaneous auricular vagus nerve stimulation (staVNS)

Clinical Study ID

NCT06742788
KY20242351liuyonghong
  • Ages 20-40
  • All Genders

Study Summary

The goal of this clinical trial is to learn if Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) enhance outcomes of in vitro fertilization (IVF). It will also learn about the safety of taVNS. The main questions it aims to answer are:

Does taVNS improve the clinical pregnancy rate of infertility patients undergoing 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 2 hours daily, with the sessions divided into four 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subjects aged 20 to 40 years, diagnosed with infertility, and preparing to undergoIVF treatment;

  2. Female subjects with anti-Müllerian hormone (AMH) > 1.2 ng/mL;

  3. Scoring at mild-to-moderate levels of impairment on anxiety, and depression scales;

  4. Both the subject and their family sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. The subject had been treated with taVNS in the past;

  2. Subjects preparing to undergo frozen embryo transfer;

  3. Subjects with a history of mental disorder or who score at a severe level ofimpairment on anxiety and depression scales;

  4. Taking sedatives, anxiety, depression, or psychiatric medications;

  5. Comorbidities including arrhythmia, hypertension, diabetes, chronic heart and kidneydiseases;

  6. Ineligibility for enrollment assessed by a gynecologist or neurologist;

  7. MRI contraindications;

  8. Metallic implants or devices contraindicating taVNS.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Phase:
Study Start date:
March 04, 2025
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Xijing Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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