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黄体期外源性孕激素补充:IVF 患者的两项随机对照试验。

The exogenous progesterone-free luteal phase: two pilot randomized controlled trials in IVF patients.

机构信息

The Fertility Clinic, Skive Regional Hospital, Resenvej 25, Skive 7800, Denmark; Faculty of Health, Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, Aarhus 8200, Denmark.

The Fertility Clinic, Skive Regional Hospital, Resenvej 25, Skive 7800, Denmark; Faculty of Health, Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, Aarhus 8200, Denmark.

出版信息

Reprod Biomed Online. 2021 Jun;42(6):1108-1118. doi: 10.1016/j.rbmo.2021.03.011. Epub 2021 Mar 18.

DOI:10.1016/j.rbmo.2021.03.011
PMID:33931371
Abstract

RESEARCH QUESTION

Is the reproductive outcome similar after gonadotrophin-releasing hormone agonist (GnRHa) trigger followed by luteal human chorionic gonadotrophin (HCG) boluses compared with HCG trigger and a standard luteal phase support (LPS)?

DESIGN

Two open-label pilot randomized controlled trials (RCT) with 250 patients from 2014 to 2019, with a primary outcome of ongoing pregnancy per embryo transfer. Patients with ≤13 follicles on the trigger day were randomized (RCT 1) to: Group A (n = 65): GnRHa trigger followed by a bolus of 1500 IU HCG s.c. on the oocyte retrieval day (ORD) and 1000 IU HCG s.c. 4 days later, and no vaginal LPS; or Group B (n = 65): 6500 IU HCG trigger, followed by a standard vaginal progesterone LPS. Patients with 14-25 follicles on the trigger day were randomized (RCT 2) to Group C (n = 60): GnRHa trigger followed by 1000 IU HCG s.c. on ORD and 500 IU HCG s.c. 4 days later, and no vaginal LPS; or Group D (n = 60): 6500 IU HCG trigger and a standard vaginal LPS.

RESULTS

In RCT 1, the ongoing pregnancy rate was 44% (22/50) in the GnRHa group versus 46% (25/54) in the HCG trigger group (RR 0.95, 95% CI 0.62-1.45). No ovarian hyperstimulation syndrome (OHSS) was seen in Groups A or B. In RCT 2, the ongoing pregnancy rate was 51% (25/49) in the GnRHa group versus 60% (31/52) in the HCG trigger group (RR 0.86, 95% CI 0.60-1.22). The OHSS rates were 3.3% and 6.7%, respectively.

CONCLUSIONS

Although a larger-scale study is needed before standard clinical implementation, the present study supports that the exogenous progesterone-free LPS is efficacious, simple and patient-friendly.

摘要

研究问题

与 hCG 扳机和标准黄体支持(LPS)相比,促性腺激素释放激素激动剂(GnRHa)扳机后给予黄体人绒毛膜促性腺激素(hCG)冲击与 hCG 扳机和标准黄体支持(LPS)相比,对生殖结局是否相似?

设计

2014 年至 2019 年期间进行了两项开放标签的先导随机对照试验(RCT),共纳入 250 例患者,主要结局为胚胎移植后的持续妊娠率。扳机日≤13 个卵泡的患者随机分为(RCT1):A 组(n=65):GnRHa 扳机后,于取卵日(ORD)给予 1500 IU 皮下 hCG,4 天后给予 1000 IU 皮下 hCG,无阴道 LPS;或 B 组(n=65):6500 IU hCG 扳机,然后进行标准阴道孕酮 LPS。扳机日 14-25 个卵泡的患者随机分为(RCT2):C 组(n=60):GnRHa 扳机后,于 ORD 给予 1000 IU 皮下 hCG,4 天后给予 500 IU 皮下 hCG,无阴道 LPS;或 D 组(n=60):6500 IU hCG 扳机,然后进行标准阴道 LPS。

结果

在 RCT1 中,GnRHa 组的持续妊娠率为 44%(22/50),hCG 扳机组为 46%(25/54)(RR 0.95,95%CI 0.62-1.45)。A 组和 B 组均未出现卵巢过度刺激综合征(OHSS)。在 RCT2 中,GnRHa 组的持续妊娠率为 51%(25/49),hCG 扳机组为 60%(31/52)(RR 0.86,95%CI 0.60-1.22)。OHSS 发生率分别为 3.3%和 6.7%。

结论

尽管需要更大规模的研究才能在临床常规实施,但本研究支持外源性无孕激素 LPS 是有效、简单且对患者友好的。

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