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Purpose <p>The objective was to study the effect of exposure to virtual reality (VR) on clinical pregnancy rate (CPR) and anxiety levels in patients undergoing frozen embryo transfer (FET), one of the most stressful stages of the in vitro fertilization (IVF) treatment journey.</p> Methods <p>A single-site prospective experimental randomized controlled trial was conducted between 05/2019 and 05/2023. Three hundred fifty FET patients using their own oocytes, or donated oocytes/embryos (oocyte provider’s aged 21–45) were enrolled and randomized in a 1:1 ratio to the VR and control groups. Clinical pregnancy rates (CPR) were assessed at 2, 6, and 12&#xa0;weeks. Stress physiological parameters (heart rate, saliva samples, and systolic/diastolic blood pressure) and anxiety (STAI-State questionnaire) were assessed at baseline (T1), pre-FET (T2) and post-FET (T3). Patients were blinded to their group assignment at T1 and T2 measurements.</p> Results <p>Pregnancy rates at 2&#xa0;weeks were higher in the VR group than in the control group (52.6% vs. 44.6%, <i>p</i> = 0.134). The CPR increased significantly at 6&#xa0;weeks (45.7% vs. 34.9%, <i>p</i> = 0.038) and 12&#xa0;weeks (42.9% vs. 28.6%, <i>p</i> = 0.005) in the VR compared to the control group. In the multivariate logistic regression analyses, the total number of previous ovum pick-up, quality of the transferred embryo, and receiving VR exposure were the three significant predictors of increased CPR at 2, 6, and 12&#xa0;weeks. Differences in the physiological stress parameters of all participants at three timepoints were found (<i>p</i> &lt; 0.05) but did not differ between the two groups (<i>p</i> &gt; 0.05). STAI-State anxiety scores among the VR group dropped much more substantially from T2 to T3 than in the control group (mean difference of 5.2 vs. 2.7, <i>p</i> = 0.026).</p> Conclusion <p>The findings of this large-scale RCT suggest that one-time VR exposure before FET, along with other clinical factors such as the quality of transferred embryos, significantly increased CPR and decreased participants' stress and anxiety levels associated with the FET procedure.</p> Trial registration <p>Clinical Trial Registry: Clinical Trials.gov.</p> <p>Trial Registration Number: NTC04394962 <a href="https://clinicaltrials.gov/study/NCT04394962">https://clinicaltrials.gov/study/NCT04394962</a></p> <p>Registration Date: 2020–05-06.</p> <p>Date of Initial Enrollment: 2019–05-31.</p>

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A prospective experimental randomized controlled trial to investigate the effect of virtual reality (VR) technology on improving clinical pregnancy rates and lowering anxiety for IVF patients undergoing frozen embryo transfer (FET)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月2日

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  • Jak Ozsarfati,
  • Samantha Yee,
  • Michal Dviri,
  • Lilach Marom Haham,
  • Andie Blankenstein,
  • Ayesha Noman,
  • Avishai Gasner,
  • Shruti Pathak,
  • Shivani Dhanani,
  • Lianet Lopez,
  • Carly Keshen,
  • Karen Glass,
  • Prati Sharma,
  • Ari Baratz,
  • Andree Gauthier-Fisher,
  • Clifford Librach

摘要

Purpose

The objective was to study the effect of exposure to virtual reality (VR) on clinical pregnancy rate (CPR) and anxiety levels in patients undergoing frozen embryo transfer (FET), one of the most stressful stages of the in vitro fertilization (IVF) treatment journey.

Methods

A single-site prospective experimental randomized controlled trial was conducted between 05/2019 and 05/2023. Three hundred fifty FET patients using their own oocytes, or donated oocytes/embryos (oocyte provider’s aged 21–45) were enrolled and randomized in a 1:1 ratio to the VR and control groups. Clinical pregnancy rates (CPR) were assessed at 2, 6, and 12 weeks. Stress physiological parameters (heart rate, saliva samples, and systolic/diastolic blood pressure) and anxiety (STAI-State questionnaire) were assessed at baseline (T1), pre-FET (T2) and post-FET (T3). Patients were blinded to their group assignment at T1 and T2 measurements.

Results

Pregnancy rates at 2 weeks were higher in the VR group than in the control group (52.6% vs. 44.6%, p = 0.134). The CPR increased significantly at 6 weeks (45.7% vs. 34.9%, p = 0.038) and 12 weeks (42.9% vs. 28.6%, p = 0.005) in the VR compared to the control group. In the multivariate logistic regression analyses, the total number of previous ovum pick-up, quality of the transferred embryo, and receiving VR exposure were the three significant predictors of increased CPR at 2, 6, and 12 weeks. Differences in the physiological stress parameters of all participants at three timepoints were found (p < 0.05) but did not differ between the two groups (p > 0.05). STAI-State anxiety scores among the VR group dropped much more substantially from T2 to T3 than in the control group (mean difference of 5.2 vs. 2.7, p = 0.026).

Conclusion

The findings of this large-scale RCT suggest that one-time VR exposure before FET, along with other clinical factors such as the quality of transferred embryos, significantly increased CPR and decreased participants' stress and anxiety levels associated with the FET procedure.

Trial registration

Clinical Trial Registry: Clinical Trials.gov.

Trial Registration Number: NTC04394962 https://clinicaltrials.gov/study/NCT04394962

Registration Date: 2020–05-06.

Date of Initial Enrollment: 2019–05-31.