为体外受精患者建立关联、学习与正念（CALM IVF）：一项临床试验
Creating affiliations, learning, and mindfulness for in vitro fertilization patients (CALM IVF): a clinical trial.
作者信息
Whynott Rachel M, Summers Karen M, Mejia Rachel B, Segre Lisa S, Ryan Ginny, Pawlak Stacey A
机构信息
Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, University of Washington, Seattle, Washington.
Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, University of Iowa Carver College of Medicine, Iowa City, Iowa.
出版信息
F S Rep. 2023 Jan 7;4(1):61-71. doi: 10.1016/j.xfre.2023.01.002. eCollection 2023 Mar.
OBJECTIVE
Determine if group psychoeducational support can improve in vitro fertilization (IVF) patients' quality of life (QoL).
DESIGN
Randomized controlled trial (NCT04048772).
SETTING
University-affiliated IVF clinic.
PATIENTS
Women (n = 76) and male partners undergoing initial autologous IVF cycle from August 2019, to December 2020.
INTERVENTIONS
Couples were assigned to groups based on projected oocyte retrieval date. Groups were randomly assigned to the control or intervention arm. Clinic closures because of the COVID-19 pandemic delayed treatment for a portion of participants. Groups were conducted in person before and virtually during the pandemic.
MAIN OUTCOME MEASURES
The primary outcome was a change in fertility quality of life (FertiQoL) from baseline to 3 days after retrieval. Secondary outcomes were changes in depression (Patient Health Questionnaire 9), anxiety (Generalized Anxiety Disorder 7), resilience (Connor-Davidson Resilience scale), IVF knowledge scores, and the likelihood of return to treatment.
RESULTS
Knowledge scores among women in Creating Affiliations, Learning, and Mindfulness (CALM) for IVF groups significantly increased compared with control (mean difference 13.19 [3.53 - 22.84]) before the pandemic. During the pandemic, women in CALM IVF had significant improvement in the social FertiQoL score compared with controls (10.42 [1.79 - 19.04]). Compared with controls, male CALM IVF participants had significantly greater improvement in total FertiQoL (mean difference 6.68 [0.39 - 12.98]), treatment FertiQoL (8.26 [0.69 - 15.82]), and resilience (Connor-Davidson 1.13 [0.54 - 1.72]). Immediate return to care did not significantly differ between arms.
CONCLUSIONS
For women undergoing IVF, group psychoeducational programs can improve IVF knowledge and social QoL during a pandemic. Participation in a group psychoeducational program can improve QoL and resilience in IVF dyad male partners.
CLINICAL TRIAL REGISTRATION NUMBER
Trial registration NCT04048772.
目的
确定团体心理教育支持能否改善体外受精（IVF）患者的生活质量（QoL）。
设计
随机对照试验（NCT04048772）。
地点
大学附属IVF诊所。
患者
2019年8月至2020年12月期间接受首次自体IVF周期治疗的女性（n = 76）及其男性伴侣。
干预措施
根据预计的取卵日期将夫妇分组。各小组被随机分配至对照组或干预组。由于新冠疫情导致诊所关闭，部分参与者的治疗被推迟。小组活动在疫情前为面对面形式，疫情期间为线上形式。
主要观察指标
主要结局是从基线到取卵后3天的生育生活质量（FertiQoL）变化。次要结局包括抑郁（患者健康问卷9）、焦虑（广泛性焦虑障碍7）、心理韧性（Connor-Davidson心理韧性量表）、IVF知识得分的变化，以及返回治疗的可能性。
结果
在疫情前，与对照组相比，体外受精的建立联系、学习和正念（CALM）组中女性的知识得分显著提高（平均差异13.19 [3.53 - 22.84]）。在疫情期间，与对照组相比，CALM IVF组中的女性在社交FertiQoL得分方面有显著改善（10.42 [1.79 - 19.04]）。与对照组相比，CALM IVF组中的男性参与者在总FertiQoL（平均差异6.68 [0.39 - 12.98]）、治疗FertiQoL（8.26 [0.69 - 15.82]）和心理韧性（Connor-Davidson 1.13 [0.54 - 1.72]）方面有显著更大的改善。两组在立即返回治疗方面无显著差异。
结论
对于接受IVF治疗的女性，团体心理教育项目可以在疫情期间提高IVF知识和社交生活质量。参与团体心理教育项目可以提高IVF夫妇男性伴侣的生活质量和心理韧性。
临床试验注册号
试验注册号NCT04048772。
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