Clinical trial NCT06742788: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing In Vitro Fertilization
Official title: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Pregnancy Outcomes of Infertility Patients Undergoing In Vitro Fertilization：A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility Assisted Reproductive Technology
Keywords: Infertility
Assisted Reproductive Techniques
Transcutaneous Auricular Vagus Nerve Stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: The primary efficacy outcome of the study is to measure and compare the difference in CPR among three groups 4 weeks after ET.
Secondary outcomes:
measure: the total number of oocytes retrieved
timeFrame: On the day of oocyte retrieval
measure: high-quality embryo rate
timeFrame: On the day of embryo transfer (day 14)
measure: the positive rate of hCG
timeFrame: The positive rate of hCG will also be observed two weeks after ET
measure: The Fertility Quality of Life Scale (FertiQoL, Simplified Chinese version)
timeFrame: The scale will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
measure: 14-item Hamilton Anxiety Rating Scale (HAMA-14)
timeFrame: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
measure: 17-item Hamilton Depression Rating Scale (HAMD-17)
timeFrame: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Yonghong Liu
role: PRINCIPAL_INVESTIGATOR
References: