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在子宫输卵管造影术中使用油性或水性对比剂行输卵管通液术治疗不孕:一项随机试验的长期生殖结局。

Tubal flushing with oil-based or water-based contrast at hysterosalpingography for infertility: long-term reproductive outcomes of a randomized trial.

机构信息

Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

出版信息

Fertil Steril. 2020 Jul;114(1):155-162. doi: 10.1016/j.fertnstert.2020.03.022. Epub 2020 Jun 16.

Abstract

OBJECTIVE

To determine the impact of oil-based versus water-based contrast on pregnancy and live birth rates ≤5 years after hysterosalpingography (HSG) in infertile women.

DESIGN

A 5-year follow-up study of a multicenter randomized trial.

SETTING

Hospitals.

PATIENT(S): Infertile women with an ovulatory cycle, 18-39 years of age, and having a low risk of tubal pathology.

INTERVENTION(S): Use of oil-based versus water-based contrast during HSG.

MAIN OUTCOME MEASURE(S): Ongoing pregnancy, live births, time to ongoing pregnancy, second ongoing pregnancy.

RESULT(S): A total of 1,119 women were randomly assigned to HSG with oil-based contrast (n = 557) or water-based contrast (n = 562). After 5 years, 444 of 555 women in the oil group (80.0%) and 419 of 559 women in the water group (75.0%) had an ongoing pregnancy (relative risk [RR] 1.07; 95% confidence interval [CI] 1.00-1.14), and 415 of 555 women in the oil group (74.8%) and 376 of 559 women in the water group (67.3%) had live births (RR 1.11; 95% CI 1.03-1.20). In the oil group, 228 pregnancies (41.1%) were conceived naturally versus 194 (34.7%) pregnancies in the water group (RR 1.18; 95% CI 1.02-1.38). The time to ongoing pregnancy was significantly shorter in the oil group versus the water group (10.0 vs. 13.7 months; hazard ratio, 1.25; 95% CI 1.09-1.43). No difference was found in the occurrence of a second ongoing pregnancy.

CONCLUSION(S): During a 5-year time frame, ongoing pregnancy and live birth rates are higher after tubal flushing with oil-based contrast during HSG compared with water-based contrast. More pregnancies are naturally conceived and time to ongoing pregnancy is shorter after HSG with oil-based contrast.

CLINICAL TRIAL REGISTRATION NUMBER

Netherlands Trial Register (NTR) 3270 and NTR6577(www.trialregister.nl).

摘要

目的

确定在子宫输卵管造影术(HSG)后 5 年内,油性与水性造影剂对不孕女性的妊娠率和活产率的影响。

设计

一项多中心随机试验的 5 年随访研究。

地点

医院。

患者

有排卵周期、年龄在 18-39 岁且患输卵管疾病风险较低的不孕女性。

干预措施

在 HSG 中使用油性与水性造影剂。

主要观察指标

持续性妊娠、活产、持续性妊娠时间、第二次持续性妊娠。

结果

共有 1119 名女性被随机分配到 HSG 中使用油性造影剂(n=557)或水性造影剂(n=562)。5 年后,油性组的 555 名女性中有 444 名(80.0%)和水性组的 559 名女性中有 419 名(75.0%)发生了持续性妊娠(相对风险[RR]1.07;95%置信区间[CI]1.00-1.14),油性组的 555 名女性中有 415 名(74.8%)和水性组的 559 名女性中有 376 名(67.3%)发生了活产(RR 1.11;95%置信区间[CI]1.03-1.20)。在油性组中,228 次妊娠(41.1%)为自然受孕,而水性组中为 194 次(34.7%)(RR 1.18;95%置信区间[CI]1.02-1.38)。与水性组相比,油性组的持续性妊娠时间明显缩短(10.0 个月对 13.7 个月;风险比,1.25;95%置信区间[CI]1.09-1.43)。在发生第二次持续性妊娠方面,两组间无差异。

结论

在 5 年的时间内,与水性造影剂相比,HSG 中使用油性造影剂进行输卵管冲洗后,妊娠率和活产率更高。油性造影剂组自然受孕的妊娠更多,持续性妊娠的时间更短。

临床试验注册号

荷兰临床试验注册中心(NTR)3270 和 NTR6577(www.trialregister.nl)。

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