Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation.

Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation.
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DOI:
10.1007/s43032-021-00705-0
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发表时间:
2022-03
期刊:
Reproductive sciences (Thousand Oaks, Calif.)
影响因子:
--
通讯作者:
Santoro N
Santoro N
中科院分区:
其他
文献类型:
--
作者:
Pretzel S;Kuhn K;Pal L;Polotsky A;Taylor HS;Zhang H;Robins J;Young SL;Santoro N

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子宫内膜异位症女性IVF前使用GnRH拮抗剂治疗(PREGnant)试验(clinicaltrials.gov编号NCT 04173169)旨在检验以下假设:在有记录的子宫内膜异位症女性中使用口服GnRH拮抗剂进行60天预治疗并计划IVF周期将导致活产率上级安慰剂。需要来自4个国家地点的814名女性。为了确定使用电子病历(EMR)为基础的战略,招募204名参与者在科罗拉多网站的可行性,我们进行了一项调查的妇女在UCHealth系统。使用相关ICD-10代码确定的合格女性被邀请完成一项6个问题的调查,以评估IVF的计划使用情况、参与的潜在兴趣以及因COVID-19导致的治疗延迟是否会影响其参与决定。在6354名符合年龄条件的子宫内膜异位症妇女中,421名同时诊断为不孕症。在消除重复后,212人通过电子邮件发送了一份调查; 76人(36%)回复,其中6人报告没有子宫内膜异位症诊断。在剩下的70人中,29人(41%)计划生育治疗;只有19人计划试管婴儿。所有19人都表示有兴趣参加。截至8/19,COVID-19治疗延迟未被视为影响参与的因素;其余11人认为这会“在一定程度上”影响他们的决定。无一报告因COVID-19而不考虑参与。基于EMR的子宫内膜异位症临床试验招募是可行的,尽管参与者的总体产量较低。COVID-19导致的治疗延迟似乎并没有过度影响潜在的招募。
The Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis (PREGnant) Trial (clinicaltrials.gov no. NCT04173169) was designed to test the hypothesis that 60-day pre-treatment with an oral GnRH antagonist in women with documented endometriosis and planning an IVF cycle will result in a superior live birth rate to placebo. Eight hundred fourteen women are required from 4 national sites. To determine the feasibility of using an electronic medical record (EMR)-based strategy to recruit 204 participants at the Colorado site, we conducted a survey of women within the UCHealth system. Eligible women, identified using relevant ICD-10 codes, were invited to complete a 6-question survey to assess planned utilization of IVF, potential interest in participation, and whether delays in treatment due to COVID-19 would influence their decision to participate. Of 6354 age-eligible women with an endometriosis diagnosis, 421 had a concurrent infertility diagnosis. After eliminating duplicates, 212 were emailed a survey; 76 (36%) responded, 6 of whom reported no endometriosis diagnosis. Of the remaining 70, 29 (41%) were planning fertility treatment; only 19 planned IVF. All 19 expressed interest in participation. COVID-19 delays in treatment were not considered as a factor affecting participation by 8/19; the remaining 11 felt that it would “somewhat” affect their decision. None reported that they would not consider participation because of COVID-19. EMR-based recruitment for an endometriosis clinical trial is feasible although the overall yield of participants is low. Delays in treatment due to COVID-19 did not appear to overly influence potential recruitment.
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