Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial.

Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial.
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在Creighton模型生育系统中的指导对经过验证的繁殖力夫妇的妊娠时间的影响:随机试验的结果。

DOI:
10.1111/ppe.12141
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发表时间:
2014-09
影响因子:
2.8
通讯作者:
Varner MW
Varner MW
中科院分区:
医学3区
文献类型:
--
作者:
Stanford JB;Smith KR;Varner MW

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Creighton Model FertilityCare System(CRMS)教女性识别性交可能导致怀孕的日子。我们试图通过每个周期的妊娠率(受孕率)来评估CRM对临床确定妊娠时间(TTP)的影响。2003-2006年间,我们在犹他大学医学院进行了一项平行的随机试验。年龄在18岁到35岁之间的女性,在被证实有生育能力的关系中,她们想要怀孕,她们被随机分组,按年龄分层,通过不透明的按顺序编号的密封信封隐藏分配。对照组接受每周性交2~3次的建议,干预组接受CRMS指导。所有女性都被要求开始尝试受孕,开始研究的第二个周期,并被积极跟踪,直到7个周期,没有研究人员失明。我们计算了描述性统计和繁殖力,并估计了TTP的COX模型。登记:ClinicalTrials.gov NCT00161395共有143名妇女随机参加:71名参加对照组(全部分析),72名参加CRMS组(69名参加分析)。CRM对TTP影响的调整危险比为0.86(95%CI:0.53,1.38)。对照组受精率为31%,CRM组受精率为36%(p=0.32)。在第一个周期,对照组受精率为17%,CRM组受精率为4%(p=0.02)。没有不良反应的报道。我们发现CRM对TTP或受精力没有显著影响,但接受CRM的妇女中,第一个周期受孕的较少。
The Creighton Model FertilityCare System (CrMS) teaches women to identify days when intercourse is likely to result in pregnancy. We sought to assess the impact of the CrMS on time to clinically identified pregnancy (TTP), via per-cycle pregnancy rates (fecundability). We conducted a parallel randomised trial at the University of Utah School of Medicine, 2003–2006. Women ages 18–35, in a relationship of proven fertility, who desired to conceive, were block-randomised, stratified for age, with allocation concealment by opaque sequentially numbered sealed envelopes. The control group received the advice to have intercourse 2–3 times per week, and the intervention group received CrMS instruction. All women were asked to begin trying to conceive starting the second cycle in the study and were followed actively up to 7 cycles, without blinding of research personnel. We calculated descriptive statistics and fecundability, and estimated Cox models for TTP. Registration: Clinicaltrials.gov NCT00161395 There were 143 women randomised: 71 to the control group (all analysed) and 72 to the CrMS group (69 analysed). The adjusted hazard ratio for the influence of CrMS on TTP was 0.86 (95% CI: 0.53, 1.38). Fecundability in cycles with intent to conceive was 31% in controls and 36% with CrMS (p=0.32). By the first cycle, fecundability was 17% in controls, and 4% with CrMS (p=0.02). No adverse events were reported. We found no significant impact of CrMS on TTP or fecundability, but fewer of the women receiving CrMS conceived by the first cycle.