Actively Recruiting
The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
Led by Xijing Hospital · Updated on 2025-07-02
90
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 20 to 40 years and diagnosed with infertility preparing for IVF treatment
- Female with anti-Müllerian hormone (AMH) level greater than 1.2 ng/mL
- Mild-to-moderate anxiety or depression scores
- Informed consent signed by participant and family
You will not qualify if you...
- Previous treatment with transcutaneous auricular vagus nerve stimulation (taVNS)
- Preparing for frozen embryo transfer
- History of mental disorder or severe anxiety or depression
- Currently taking sedatives, anxiety, depression, or psychiatric medications
- Having arrhythmia, hypertension, diabetes, chronic heart or kidney diseases
- Deemed ineligible by a gynecologist or neurologist
- Having metallic implants or devices that contraindicate taVNS
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
X
Xiaofei Fei
CONTACT
Y
Yonghong Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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