低剂量阿司匹林对多囊卵巢综合征女性卵巢过度刺激综合征发生及辅助生殖技术结局的影响：一项随机双盲临床试验

Effect of low-dose aspirin on the development of ovarian hyperstimulation syndrome and outcomes of assisted reproductive techniques in the women with PCOS, a randomized double-blinded clinical trial.

作者信息

Namavar Jahromi Bahia, Zolghadri Jaleh, Rahmani Elham, Alipour Shohreh, Anvar Zahra, Zarei Afsun, Keramati Pegah

机构信息

Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

OB and GYN Ward, Bushehr University of Medical Sciences, Bushehr, Iran.

出版信息

Taiwan J Obstet Gynecol. 2019 Mar;58(2):255-260. doi: 10.1016/j.tjog.2019.01.016.

DOI:10.1016/j.tjog.2019.01.016

PMID:30910149

Abstract

OBJECTIVE

Ovarian hyperstimulation syndrome (OHSS) is a major complication of assisted reproductive technologies (ART). Polycystic ovary syndrome (PCOS) is a risk factor for OHSS. The aim of this randomized clinical trial (RCT) was to study the effect of low-dose aspirin (LDA) on the development of OHSS and ART outcomes in PCOS during ART.

MATERIALS AND METHODS

This double-blinded placebo controlled RCT was performed on 232 PCOS infertile women in their first ART cycles during 2010-2016. LDA and placebo capsules were prepared, packed and specified by code numbers in similar shapes. One package was given to every woman and asked to take one capsule/day since the 21st day of her cycle prior to the gonadotropin stimulation. Gonadotropin releasing hormone agonist long protocol and triggering by human chorionic gonadotropin were used. Development of moderate to severe OHSS and their ART outcomes were documented then the codes were broken and data analyzed. Chi-square and Mann-Whitney U tests were used for the statistical analyses.

RESULTS

Eighteen cases that did not follow the study design were excluded. 214 cycles remained for the final analyses with 109 cases in LDA and 105 in the placebo group. Rate of the moderate to severe OHSS in LDA group was 34.9% compared to 30.5% in placebo group (P = 0.494). Fertilization rate was 71.8% vs 65.1% (P = <0.001) and the mean number of grade III embryos were 3.28 ± 3.53 vs 1.46 ± 1.42 (P = 0.014) in LDA and placebo groups, respectively. The mean number of the oocytes in different grades, total and frozen embryos also implantation and clinical pregnancy rates were not different between the groups.

CONCLUSION

Moderate to Severe OHSS was not decreased but fertilization rate and the mean number of poor quality embryos were increased in LDA arm.

REGISTRATION NUMBER

IRCT 201105216541N1.

摘要

目的

卵巢过度刺激综合征（OHSS）是辅助生殖技术（ART）的主要并发症。多囊卵巢综合征（PCOS）是OHSS的一个危险因素。这项随机临床试验（RCT）的目的是研究低剂量阿司匹林（LDA）对PCOS患者在ART期间OHSS发生及ART结局的影响。

材料与方法

这项双盲安慰剂对照RCT于2010 - 2016年对232名处于首次ART周期的PCOS不孕女性进行。制备LDA和安慰剂胶囊，以相似形状按编号包装并标注。每位女性发放一包，要求从促性腺激素刺激前周期的第21天起每天服用一粒胶囊。采用促性腺激素释放激素激动剂长方案及人绒毛膜促性腺激素扳机。记录中重度OHSS的发生情况及其ART结局，然后解密代码并进行数据分析。采用卡方检验和曼 - 惠特尼U检验进行统计分析。

结果

18例未遵循研究设计的病例被排除。最终分析纳入214个周期，LDA组109例，安慰剂组105例。LDA组中重度OHSS发生率为34.9%，安慰剂组为30.5%（P = 0.494）。LDA组和安慰剂组的受精率分别为71.8%和65.1%（P = <0.001），平均优质胚胎数分别为3.28 ± 3.53和1.46 ± 1.42（P = 0.014）。不同等级卵母细胞的平均数量、总胚胎数和冷冻胚胎数以及着床率和临床妊娠率在两组间无差异。