Using a device to stimulate the vagus nerve to improve IVF outcomes in infertility patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.