Department of Reproductive Medicine, VU University Medical Centre, De Boelelaan 1118, 1081 HZ Amsterdam, The Netherlands.
Department of Epidemiology and Biostatistics, VU University Medical Centre, De Boelelaan 1118, 1081 HZ Amsterdam, The Netherlands.
Hum Reprod. 2017 Nov 1;32(11):2218-2224. doi: 10.1093/humrep/dex302.
Does 15 min of immobilization after IUI improve pregnancy rates?
Immobilization for 15 min after IUI does not improve pregnancy rates.
Prior RCTs report a beneficial effect of supine immobilization for 15 min following IUI compared to immediate mobilization, however, these studies can be criticized. Given the importance for the logistics in daily practice and the lack of biological plausibility we planned a replication study prior to potential implementation of this procedure.
STUDY DESIGN, SIZE, DURATION: A single centre RCT, based in an academic setting in the Netherlands, was performed. Participants were randomly assigned for 15 min of supine immobilization following IUI for a maximum of six cycles compared to the standard procedure of immediate mobilization following IUI. Participants and caregivers were not blinded to group assignment. An independent researcher used computer-generated tables to allocate treatments. Stratification occurred to the indication of IUI (unexplained or mild male subfertility). Revelation of allocation took place just before the insemination by the caregiver. The primary outcome was ongoing pregnancy rate per couple.
PARTICIPANTS/MATERIALS, SETTING, METHODS: A total of 498 couples diagnosed with unexplained or mild male subfertility and an indication for treatment with IUI were approached and randomized in the study, of which 244 participants were assigned to 15 min of supine immobilization and 254 participants to immediate mobilization.
Participant characteristics were comparable between the groups, and 236 participants were analysed in the immobilization group, versus 245 in the mobilization group. The ongoing pregnancy rate per couple was not found to be superior in the immobilization group (one-sided P-value = 0.97) with 76/236 ongoing pregnancies (32.2%) being accomplished in the immobilization and 98/245 ongoing pregnancies (40.0%) in the immediate mobilization group (relative risk 0.81; 95% CI [0.63, 1.02], risk difference: -7.8%, 95% CI [-16.4%, 0.8%]). No difference was found in miscarriage rate, multiple gestation rate, live birth rate and time to pregnancy between the groups.
LIMITATIONS, REASONS FOR CAUTION: Owing to discontinuation of the planned treatment not all participants reached six IUI cycles or an ongoing pregnancy. However, this is as expected in IUI treatment and mirrors clinical practice. These participants were equally distributed across the two groups. Women with tubal pathology and endocrine disorders were excluded for this trial, and this might narrow generalizability.
This study shows no positive effect of 15 min of immobilization following IUI on pregnancy rates. Based on available evidence today, including our study, a possible beneficial effect of supine immobilization after IUI is at least doubtful and straightforward implementation does not seem to be justified.
STUDY FUNDING/COMPETING INTEREST(S): No funding was received. All authors have nothing to disclose.
Dutch Trial Register NTR 2418.
20 July 2010.
DATE OF FIRST PATIENT'S ENROLMENT: 11 August 2010.
IUI 后 15 分钟的固定是否能提高妊娠率？
IUI 后 15 分钟的固定并不能提高妊娠率。
先前的随机对照试验（RCT）报告称，与 IUI 后立即活动相比，IUI 后 15 分钟的仰卧位固定对妊娠率有有益的影响，但这些研究可能存在争议。鉴于在日常实践中对后勤工作的重要性以及缺乏生物学上的合理性，我们计划在潜在实施该程序之前进行复制研究。
研究设计、大小和持续时间：这是一项在荷兰一所学术机构进行的单中心 RCT。参与者被随机分配接受 IUI 后 15 分钟的仰卧位固定，最多进行六次周期，而标准程序是 IUI 后立即活动。参与者和护理人员对分组分配不知情。一位独立的研究人员使用计算机生成的表格来分配治疗方法。根据 IUI 的指征（不明原因或轻度男性不育）进行分层。护理人员在授精前才揭示分组。主要结局是每对夫妇的持续妊娠率。
参与者/材料、设置和方法：共有 498 对被诊断为不明原因或轻度男性不育且有 IUI 治疗指征的夫妇被纳入研究并进行了随机分组，其中 244 名参与者被分配到 15 分钟的仰卧位固定组，254 名参与者被分配到立即活动组。
参与者的特征在两组之间是可比的，在固定组中分析了 236 名参与者，而在活动组中分析了 245 名参与者。未发现固定组的持续妊娠率更高（单侧 P 值=0.97），固定组中有 76/236 名持续妊娠（32.2%），而立即活动组中有 98/245 名持续妊娠（40.0%）（相对风险 0.81；95%CI[0.63,1.02]，风险差异：-7.8%，95%CI[-16.4%，0.8%]）。两组之间的流产率、多胎妊娠率、活产率和妊娠时间均无差异。
局限性、谨慎的原因：由于计划治疗的中断，并非所有参与者都完成了六次 IUI 周期或实现了持续妊娠。然而，这在 IUI 治疗中是预期的，反映了临床实践。这些参与者在两组中均匀分布。该试验排除了有输卵管病变和内分泌紊乱的女性，这可能会限制其普遍性。
本研究表明，IUI 后 15 分钟的固定对妊娠率没有积极影响。根据目前现有的证据，包括我们的研究，IUI 后仰卧位固定的可能有益效果至少值得怀疑，直接实施似乎没有道理。
研究资金/利益冲突：未收到任何资助。所有作者均无利益冲突。
荷兰试验注册处 NTR 2418。
2010 年 7 月 20 日。
2010 年 8 月 11 日。
