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临床试验/NCT04394962
NCT04394962已完成不适用

The Use of Virtual Reality Technology in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer: A Randomized Controlled Trial

Dr cliff Librach2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
2
主要终点
Clinical pregnancy rate (CPR)

研究概览

简要总结

The study will examine the effect of exposure to virtual reality on stress levels and pregnancy rates, in infertile women undergoing in vitro fertilization embryo transfer

详细描述

In vitro fertilization (IVF) treatment involving ovarian stimulation, oocyte retrieval and embryo transfer (ET) is an effective treatment for various causes of infertility. Despite advances in ovarian stimulation regimens and laboratory conditions, many IVF cycles do not result in pregnancy, and repeated treatment cycles are required. According to the latest Assisted reproductive technology (ART) surveillance report in the United states, of 143,286 procedures that progressed to the ET stage, 50.9% resulted in a pregnancy and 41.4% in a live-birth. Achieving higher pregnancy and live birth rates remains a leading priority of IVF units worldwide. Both IVF practitioners and patients keep searching for new ways to improve reproductive outcomes.

IVF is a multidimensional stressor. The treatment itself constitutes the primary stressor and is most likely to evoke anxiety. The highest anxiety scores were experienced before embryo transfer and were comparable to anxiety scores obtained from surgical female patients in the immediate preoperative period. Hence, it is not surprising that ET is defined by many investigators as a crucial event for determining IVF outcome, and many patients perceive it as the culmination of the IVF treatment. The stress this procedure may cause can result in a variety of autonomous nervous system expressions, altered uterine gene expression, resulting in decreased uterine receptivity, or an increase in uterine contraction frequency, which may be inversely correlated to embryo implantation and pregnancy rates in IVF. Several studies found that women who did not become pregnant with IVF, reported experiencing more stress during treatment than those who achieved pregnancy.

Although the exact mechanism whereby stress interferes with reproductive processes is not fully understood, experimental evidence increasingly indicates that lower stress levels result in better fertility treatment outcome.

The use of complementary medicine or adjuvant therapies to reduce psychological stress during ART therapy and improve IVF outcomes is increasing. Various alternative therapies have been proposed to improve reproductive outcomes during IVF treatment, such as acupuncture and Chinese herbal medicines. However, the impact of these therapies on IVF outcomes was inconclusive.

The impact of medical clowning as a stress-reducing technique for 12-15 minutes after ET was found to increase the pregnancy rate - 36.4% in the intervention group compared with 20.2% in the control group. Other interventions, specifically prior or during the IVF-ET procedure itself have been studied in the context of improving cycle outcome and/or reducing anxiety levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

盲法说明

The Physician performing the embryo transfer will be blinded to the patient's group randomization

入排标准

年龄范围
21 Years 至 54 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 21-45-year-old female patients, if using own ovum. Patients above this age range may be approached for study if using a donated ovum, as long as "egg age" (age of donor at ovum pick up) falls in 21-45 age range.
  • Undergoing frozen ET procedures, and approached for study on "Day 2 - Day 4" of ET transfer cycle.
  • Ability to provide written consent to use VR technology before the ET procedure

排除标准

  • Contraindication to use VR technology (Epilepsy/previous seizure, claustrophobia, current migraine, heart disease, visual and/or auditory deficits/use of medical devices such as cardiac pacemaker or hearing aids)
  • Anxiety disorder and/or Regular use of anti-anxiety medications
  • Major uterine anomalies and/or uterine fibroids distorting the cavity

研究组 & 干预措施

Control group

No Intervention

Patients who will be randomized to the control group will be waiting for the ET procedure without any intervention and without any deviation from the standard of care

Study group

Experimental

Exposure to virtual reality environment exposure

干预措施: Virtual reality (Device)

结局指标

主要结局

Clinical pregnancy rate (CPR)

时间窗: Assessed 4 weeks after ET (= 6 weeks of gestation)

The difference in CPR (determined by sonographic evidence of a gestational sac and fetal heart rate at 6 weeks' gestation by transvaginal ultrasound) between the study and the control group. An increase of 15% in the clinical pregnancy rate in the study group will be considered as significant.

次要结局

  • Stress levels - STAI questionnaires(Questionnaires will be filled out in 3 different time points during the study: 1) Day 1 of recruitment, before beginning the medications for endometrial preparation 2) ET day, 30-60 minutes before ET 3) ET day, 5-10 minutes after ET procedure)
  • Salivary alpha amylase (SAA) levels(Samples will be collected in 3 different time points during the study: 1) Day 1 of recruitment, before beginning the medications for endometrial preparation 2) ET day, 30-60 minutes before ET 3) ET day, 5-10 minutes after ET procedure)
  • Sympathetic autonomous nervous system expressions(Measurements will be taken in 3 different time points during the study: 1) Day 1 of recruitment, before beginning the medications for endometrial preparation 2) 30-60 minutes before ET 3) ET day, 5-10 minutes after ET procedure)

研究者

发起方
Dr cliff Librach
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr cliff Librach

Clifford Librach, MD, FRCS(C), FACOG(REI), Director of the Create Fertility Centre, Professor, Department of Obstetrics and Gynecology, University of Toronto

Create Fertility Center

研究点 (2)

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