The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
NCT ID: NCT06742788
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-03-04
2025-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the taVNS group
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.
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.
the staVNS group
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.
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.
the IVF control group
The IVF control group refers to receiving only in vitro fertilization (IVF) treatment without any additional Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) treatment.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
40 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Liu Yonghong, MD
Associate Director of Neurology
Principal Investigators
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Yonghong Liu
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20242351liuyonghong
Identifier Type: -
Identifier Source: org_study_id
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