The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
DeviceTranscutaneous 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 study will use the Chinese National Institutes for Food and Drug Control certificated taVNS device TVNS-100 (Xinzhile Medical Technology Co., Jiangxi, China). The study includes an intervening period of 4 weeks.
sham transcutaneous auricular vagus nerve stimulation (staVNS)
DeviceThe 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 National Institutes for Food and Drug Control certificated taVNS device TVNS-100 (Xinzhile Medical Technology Co., Jiangxi, China). The study includes an intervening period of 4 weeks.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: the taVNS groupExperimental treatment 1 intervention
Group B: the staVNS groupSham comparator 1 intervention
Group C: the IVF control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
the recruitment rate
The recruitment rate refers to the number of eligible individuals screened.
Time frame
The time frame for the recruitment rate is 12 months after the intervention begins.2
the enrollment rate
The the enrollment rate refers to the proportion of eligible patients who consent to participate.
Time frame
The time frame for the enrollment rate is 12 months after the intervention begins.3
the retention rate
The retention rate refers to the proportion of enrolled individuals who do not withdraw from the intervention.
Time frame
The time frame for the retention rate spans from baseline to 4 weeks after ET.4
the patient adherence
The patient adherence refers to the proportion of patients who complete the intervention.
Time frame
The time frame for patient adherence spans from baseline to 4 weeks after ET.Secondary outcomes
1
the total number of oocytes retrieved
Time frame
On the day of oocyte retrieval2
high-quality embryo rate
Time frame
On the day of embryo transfer (day 14)3
the positive rate of hCG
The hCG level, specifically defined as \>10 mIU/mL, is an important indicator of pregnancy success.
Time frame
The positive rate of hCG will also be observed two weeks after ET4
Clinical Pregnancy Rate
Description: 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.
Time frame
The primary efficacy outcome of the study is to measure and compare the difference in CPR among three groups 4 weeks after ET.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov