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

RecruitingNAAges 20 Years - 40 YearsAllXijing Hospital
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In plain words

What the trial is, and whether it could suit you

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 hou

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subjects aged 20 to 40 years, diagnosed with infertility, and preparing to undergo IVF 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 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 of impairment on anxiety and depression scales; 4. Taking sedatives, anxiety, depression, or psychiatric medications; 5. Comorbidities including arrhythmia, hypertension, diabetes, chronic heart and kidney diseases; 6. Ineligibility for enrollment assessed by a gynecologist or neurologist; 7. Metallic implants or devices contraindicating taVNS.
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What it tests

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  • sham transcutaneous auricular vagus nerve stimulation (staVNS)
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Where

1 site
Xijing Hospital
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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