Using a device to stimulate the vagus nerve to improve IVF outcomes in infertility patients
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
This study is testing if a device that stimulates the vagus nerve can help improve pregnancy rates for people undergoing in vitro fertilization (IVF).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06742788 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) can enhance pregnancy outcomes for infertility patients undergoing in vitro fertilization (IVF). Participants will use the taVNS device for two hours daily, divided into four sessions, while a control group will use a sham device. The study aims to compare the clinical pregnancy rates between the taVNS group and the sham group, as well as assess the safety of the taVNS device. Participants will also maintain a diary to record any adverse events during the trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 40 with infertility issues who are preparing for IVF and have mild-to-moderate anxiety or depression.
Not a fit: Patients with severe mental health issues, certain comorbidities, or those who have previously used taVNS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pregnancy rates for patients undergoing IVF.
How similar studies have performed: While the use of taVNS in this context is novel, similar approaches in other areas have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Yonghong Liu — Xijing Hospital
- Study coordinator: Xiaofei Fei
- Email: feixiaofeixzyz@126.com
- Phone: +8613822311264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.