The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is an emerging, non-invasive adjunctive therapy. 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. The s
• Устройство sham transcutaneous auricular vagus nerve stimulation (staVNS)
  The sham transcutaneous auricular vagus nerve stimulation (staVNS) serves as a sub-threshold therapeutic stimulus functions as a sham stimulus. 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 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. The study will use the Chinese Natio

Первичные конечные точки

• the recruitment rate [Срок оценки: The time frame for the recruitment rate is 12 months after the intervention begins.]
• the enrollment rate [Срок оценки: The time frame for the enrollment rate is 12 months after the intervention begins.]
• the retention rate [Срок оценки: The time frame for the retention rate spans from baseline to 4 weeks after ET.]
• the patient adherence [Срок оценки: The time frame for patient adherence spans from baseline to 4 weeks after ET.]

Вторичные конечные точки (8)

• the total number of oocytes retrieved [Срок оценки: On the day of oocyte retrieval]
• high-quality embryo rate [Срок оценки: On the day of embryo transfer (day 14)]
• the positive rate of hCG [Срок оценки: The positive rate of hCG will also be observed two weeks after ET]
• Clinical Pregnancy Rate [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: The scale and questionnaire measurement will be observed at baseline, the day of embryo transfer (day 14) and 2 weeks after embryo transfer.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xijing Hospital — Сиань

Идентификаторы

NCT: NCT06742788 · KY20242351liuyonghong

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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