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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •The subject had been treated with taVNS in the past;
- •Subjects preparing to undergo frozen embryo transfer;
- •Subjects with a history of mental disorder or who score at a severe level of impairment on anxiety and depression scales;
- •Taking sedatives, anxiety, depression, or psychiatric medications;
- •Comorbidities including arrhythmia, hypertension, diabetes, chronic heart and kidney diseases;
- •Ineligibility for enrollment assessed by a gynecologist or neurologist;
- •Metallic implants or devices contraindicating taVNS.
研究组 & 干预措施
the taVNS group
The taVNS group receives Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) along with In Vitro Fertilization (IVF) treatment. The taVNS protocol is configured with a pulse width of 500 µs, a frequency of 25 Hz, and a current intensity titrated to each patient's pain tolerance threshold (range: 0.5-2.0 mA). The stimulation is to be carried out for 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.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (Device)
the staVNS group
The staVNS group receives sham transcutaneous auricular vagus nerve stimulation, along with In Vitro Fertilization (IVF) treatment. The staVNS protocol is set at a pulse width of 500 µs and a frequency of 25 Hz, with an intensity value of 0.1 mA.The stimulation of 0.1 mA acts as a therapeutic signal below the threshold level and functions as a sham stimulus. The stimulation is to be carried out for 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.
干预措施: sham transcutaneous auricular vagus nerve stimulation (staVNS) (Device)
the IVF control group
The IVF control group refers to receiving only in vitro fertilization (IVF) treatment without any additional Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) treatment.
结局指标
主要结局
the recruitment rate
时间窗: The time frame for the recruitment rate is 12 months after the intervention begins.
The recruitment rate refers to the number of eligible individuals screened.
the enrollment rate
时间窗: The time frame for the enrollment rate is 12 months after the intervention begins.
The the enrollment rate refers to the proportion of eligible patients who consent to participate.
the retention rate
时间窗: The time frame for the retention rate spans from baseline to 4 weeks after ET.
The retention rate refers to the proportion of enrolled individuals who do not withdraw from the intervention.
the patient adherence
时间窗: The time frame for patient adherence spans from baseline to 4 weeks after ET.
The patient adherence refers to the proportion of patients who complete the intervention.
次要结局
- high-quality embryo rate(On the day of embryo transfer (day 14))
- the total number of oocytes retrieved(On the day of oocyte retrieval)
- 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.)
- 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.)
- 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 positive rate of hCG(The positive rate of hCG will also be observed two weeks after ET)
- 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 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 positive rate of hCG(The positive rate of hCG will also be observed two weeks after ET)
- 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 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.)
- 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.)
- 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.)
- 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.)
研究者
Liu Yonghong, MD
Associate Director of Neurology
Xijing Hospital