Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing In Vitro Fertilization

Not Applicable

Recruiting

• Conditions: Infertility Assisted Reproductive Technology

• Registration Number: NCT06742788
• Lead Sponsor: Xijing Hospital

Brief Summary

The goal of this clinical trial is to learn if Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) enhance outcomes of in vitro fertilization (IVF). It will also learn about the safety of taVNS. The main questions it aims to answer are:

Does taVNS improve the clinical pregnancy rate of infertility patients undergoing 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 2 hours daily, with the sessions divided into four 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-18
• Study Start: 2025-03-04
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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. MRI contraindications;
8. Metallic implants or devices contraindicating taVNS.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	The primary efficacy outcome of the study is to measure and compare the difference in CPR among three groups 4 weeks after ET.	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.

Secondary Outcome Measures

Name	Time	Method
the total number of oocytes retrieved	On the day of oocyte retrieval
high-quality embryo rate	On the day of embryo transfer (day 14)
the positive rate of hCG	The positive rate of hCG will also be observed two weeks after ET	The hCG level, specifically defined as \>10 mIU/mL, is an important indicator of pregnancy success.
The Fertility Quality of Life Scale (FertiQoL, Simplified Chinese version)	The scale will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.	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.
Pittsburgh Sleep Quality Index (PSQI)	The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.	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.
14-item Hamilton Anxiety Rating Scale (HAMA-14)	The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.	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.
17-item Hamilton Depression Rating Scale (HAMD-17)	The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China