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1023 名接受首次辅助生殖技术治疗的女性的生活质量及心理社会和身体健康状况:比较促性腺激素释放激素(GnRH)拮抗剂和 GnRH 激动剂方案的随机对照试验的次要结局。

Quality of life and psychosocial and physical well-being among 1,023 women during their first assisted reproductive technology treatment: secondary outcome to a randomized controlled trial comparing gonadotropin-releasing hormone (GnRH) antagonist and GnRH agonist protocols.

机构信息

Fertility Clinic Section 455, Department of Obstetrics and Gynecology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark.

Fertility Clinic Section 455, Department of Obstetrics and Gynecology, Hvidovre University Hospital, Hvidovre, Copenhagen, Denmark.

出版信息

Fertil Steril. 2018 Jan;109(1):154-164. doi: 10.1016/j.fertnstert.2017.09.020. Epub 2017 Nov 23.

Abstract

OBJECTIVE

To compare self-reported quality of life, psychosocial well-being, and physical well-being during assisted reproductive technology (ART) treatment in 1,023 women allocated to either a short GnRH antagonist or long GnRH agonist protocol.

DESIGN

Secondary outcome of a prospective phase 4, open-label, randomized controlled trial. Four times during treatment a questionnaire on self-reported physical well-being was completed. Further, a questionnaire on self-reported quality of life and psychosocial well-being was completed at the day of hCG testing.

SETTING

Fertility clinics at university hospitals.

PATIENT(S): Women referred for their first ART treatment were randomized in a 1:1 ratio and started standardized ART protocols.

INTERVENTION(S): Gonadotropin-releasing hormone analogue; 528 women allocated to a short GnRH antagonist protocol and 495 women allocated to a long GnRH agonist protocol.

MAIN OUTCOME MEASURE(S): Self-reported quality of life, psychosocial well-being, and physical well-being based on questionnaires developed for women receiving ART treatment.

RESULT(S): Baseline characteristics were similar, and response rates were 79.4% and 74.3% in the GnRH antagonist and GnRH agonist groups, respectively. Self-reported quality of life during ART treatment was rated similar and slightly below normal in both groups. However, women in the GnRH antagonist group felt less emotional (adjusted odds ratio [AOR] 0.69), less limited in their everyday life (AOR 0.74), experienced less unexpected crying (AOR 0.71), and rated quality of sleep better (AOR 1.55). Further, women receiving GnRH agonist treatment felt worse physically.

CONCLUSION(S): Women in a short GnRH antagonist protocol rated psychosocial and physical well-being during first ART treatment better than did women in a long GnRH agonist protocol. However, the one item on self-reported general quality of life was rated similarly.

CLINICAL TRIAL REGISTRATION NUMBER

NCT00756028.

摘要

目的

比较 1023 名接受辅助生殖技术(ART)治疗的女性中,报告的生活质量、心理社会健康和身体状况,这些女性被分配到短期 GnRH 拮抗剂或长期 GnRH 激动剂方案中。

设计

前瞻性 4 期、开放标签、随机对照试验的次要结果。在治疗期间,四次完成关于自我报告身体状况的问卷。此外,在 hCG 检测日完成关于自我报告生活质量和心理社会健康的问卷。

地点

大学医院的生育诊所。

患者

被转介接受首次 ART 治疗的女性,按 1:1 比例随机分组,并开始标准化的 ART 方案。

干预

促性腺激素释放激素类似物;528 名女性分配到短期 GnRH 拮抗剂方案,495 名女性分配到长期 GnRH 激动剂方案。

主要观察指标

基于为接受 ART 治疗的女性开发的问卷,报告的生活质量、心理社会健康和身体状况。

结果

基线特征相似, GnRH 拮抗剂和 GnRH 激动剂组的应答率分别为 79.4%和 74.3%。ART 治疗期间报告的生活质量相似,略低于正常水平。然而, GnRH 拮抗剂组的女性感到情绪低落(调整后的优势比 [AOR] 0.69)、日常生活受限(AOR 0.74)、意外哭泣减少(AOR 0.71),并且睡眠质量更好(AOR 1.55)。此外,接受 GnRH 激动剂治疗的女性感觉身体状况更差。

结论

接受短期 GnRH 拮抗剂方案的女性在首次 ART 治疗期间报告的心理社会和身体状况优于接受长期 GnRH 激动剂方案的女性。然而,自我报告的一般生活质量的一个项目评分相似。

临床试验注册号

NCT00756028。

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