Infertility Assisted Reproductive TechnologyNCT06742788
The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Infertility Assisted Reproductive Technology, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Infertility Assisted Reproductive Technology
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Yonghong Liu, +8629-84771377, liuyhong@fmmu.edu.cn
About this study
Official title: The Feasibility of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing in Vitro Fertilization: Study Protocol for a Pilot Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), sham transcutaneous auricular vagus nerve stimulation (staVNS)
- Keywords
- Infertility, Assisted Reproductive Techniques, Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recruitment rate
The recruitment rate refers to the number of eligible individuals screened.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The time frame for patient adherence spans from baseline to 4 weeks after ET.
Secondary outcomes (8)
the total number of oocytes retrieved
Measured: On the day of oocyte retrieval
high-quality embryo rate
Measured: On the day of embryo transfer (day 14)
the positive rate of hCG
The hCG level, specifically defined as >10 mIU/mL, is an important indicator of pregnancy success.
Measured: The positive rate of hCG will also be observed two weeks after ET
Clinical Pregnancy Rate
Description: The clinical pregnancy rate (CPR) is a measure used in reproductive medicine to evaluate the success of in vitro fertilization (IVF) treatment. It is defined as the percentage of women who achieve a clinical pregnancy from the first fresh or frozen embryo transfer cycle. A clinical pregnancy is confirmed by ultrasound and is characterized by the presence of a gestational sac within the uterine cavity, as observed 4 weeks after the embryo transfer has taken place.
Measured: 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 Fertility Quality of Life Scale yields six subscale and three total scores with a range of 0 to 100. Higher scores mean higher quality of life and a better outcome.
Measured: The scale will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
Pittsburgh Sleep Quality Index (PSQI)
The total score range of the Pittsburgh Sleep Quality Index (PSQI) is from 0 to 21. Higher scores mean poorer sleep quality and a worse outcome.
Measured: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
14-item Hamilton Anxiety Rating Scale (HAMA-14)
The total score range of the 14-item Hamilton Anxiety Rating Scale (HAMA-14) is from 0 to 56. Higher scores mean more severe anxiety and a worse outcome.
Measured: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
17-item Hamilton Depression Rating Scale (HAMD-17)
The total score range of the 17-item Hamilton Depression Rating Scale (HAMD-17) is from 0 to 68. Higher scores mean more severe depression and a worse outcome.
Measured: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start4 Mar 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yonghong, MD, Xijing Hospital
- Investigators
- Yonghong Liu, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742788
- Sponsor's protocol ID
- KY20242351liuyonghong
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing in Vitro Fertilization: Study Protocol for a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06742788
- Acronym / sponsor ID
- KY20242351liuyonghong
- Keywords
- Infertility, Assisted Reproductive Techniques, Transcutaneous Auricular Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the taVNS group | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)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. |
| the staVNS group | Sham comparator | Device: sham transcutaneous auricular vagus nerve stimulation (staVNS)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. |
| 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | the taVNS group |
| 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. | Device | the staVNS group |
Primary outcome
the recruitment rate
Time frame: The time frame for the recruitment rate is 12 months after the intervention begins.
The recruitment rate refers to the number of eligible individuals screened.
the enrollment rate
Time frame: The time frame for the enrollment rate is 12 months after the intervention begins.
The the enrollment rate refers to the proportion of eligible patients who consent to participate.
the retention rate
Time frame: The time frame for the retention rate spans from baseline to 4 weeks after ET.
The retention rate refers to the proportion of enrolled individuals who do not withdraw from the intervention.
the patient adherence
Time frame: The time frame for patient adherence spans from baseline to 4 weeks after ET.
The patient adherence refers to the proportion of patients who complete the intervention.
8 secondary outcomes
the total number of oocytes retrieved
Time frame: On the day of oocyte retrieval
high-quality embryo rate
Time frame: On the day of embryo transfer (day 14)
the positive rate of hCG
Time frame: The positive rate of hCG will also be observed two weeks after ET
Clinical Pregnancy Rate
Time frame: 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)
Time frame: The scale will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
14-item Hamilton Anxiety Rating Scale (HAMA-14)
Time frame: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yonghong Liu principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Infertility Assisted Reproductive Technology, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofei Fei (+8613822311264, feixiaofeixzyz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recruitment rate (time frame: The time frame for the recruitment rate is 12 months after the intervention begins.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.