The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF (NCT06742788) | Clinical Trial Compass
RecruitingNot Applicable
The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
China90 participantsStarted 2025-03-04
Plain-language 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.
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.
Who can participate
Age range
20 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. The subject had been treated with taVNS in the past;
. Subjects preparing to undergo frozen embryo transfer;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the recruitment rate
Timeframe: The time frame for the recruitment rate is 12 months after the intervention begins.
2
the enrollment rate
Timeframe: The time frame for the enrollment rate is 12 months after the intervention begins.
3
the retention rate
Timeframe: The time frame for the retention rate spans from baseline to 4 weeks after ET.
4
the patient adherence
Timeframe: The time frame for patient adherence spans from baseline to 4 weeks after ET.