Craciunas Laurentiu, Pickering Oonagh, Chu Justin, Žurauskienė Justina, Coomarasamy Arri
Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
Eur J Obstet Gynecol Reprod Biol. 2020 Oct;253:42-47. doi: 10.1016/j.ejogrb.2020.07.058. Epub 2020 Aug 1.
To assess the women's views in relation to the characteristics of an endometrial receptivity test in the context of recurrent miscarriage with an overarching aim to guide the development of a Target Product Profile (TPP) based on minimum acceptable ("worst-case") and ideal ("best-case") features.
This was a descriptive cross-sectional study involving a total of 131 women who answered questions related to the development of an endometrial receptivity test between December 2017 and May 2018. Women attending the recurrent miscarriage clinic at the Tommy's National Centre for Miscarriage Research in Birmingham, United Kingdom, were invited to participate. Referral criteria included two or more miscarriages irrespective of the timing in relation to successful pregnancies. The 'best-case' (ideal) and 'worst-case' (minimum acceptable) thresholds were arbitrary set to satisfy at least 80% and 40% of responders, respectively.
The ideal endometrial receptivity test should be indicated after two miscarriages to comply with the wish of 80.9% (106 women) of responders. It should be performed in a window of three to four days within the menstrual cycle (93.2%; 122 women) and results should be available within one to two days (87.7%; 115 women). Invasiveness of testing should not extend beyond a vaginal examination (85.4%; 112 women). Repeating the test should not be required more than twice (96.1%; 125 women) and the results should remain useful for at least six menstrual cycles (89.3%; 117 women). The importance score given for the endometrium was weakly associated with the willingness to pay for testing; however, there was no evidence to suggest this correlation was different from 0 (Kendall's tau = 0.1101765, z = 1.4327, p-value = 0.1519; Spearman's rho = 0.1268444, S = 327136, p-value = 0.1488).
Women understand the important role the endometrium plays for a successful pregnancy and they have specific views in relation to the indication, timing and invasiveness of testing, need for test repetition, validity of results and costs of testing.
评估女性对于复发性流产背景下子宫内膜容受性检测特征的看法，总体目标是基于最低可接受（“最坏情况”）和理想（“最佳情况”）特征来指导制定目标产品概况（TPP）。
这是一项描述性横断面研究，共有131名女性参与，她们回答了与2017年12月至2018年5月期间子宫内膜容受性检测开发相关的问题。邀请了在英国伯明翰汤米全国流产研究中心复发性流产诊所就诊的女性参与。纳入标准包括两次或更多次流产，无论与成功妊娠的时间关系如何。“最佳情况”（理想）和“最坏情况”（最低可接受）阈值分别任意设定为至少满足80%和40%的应答者。
理想的子宫内膜容受性检测应在两次流产后进行，以符合80.9%（106名女性）应答者的意愿。应在月经周期的三到四天内进行检测（93.2%；122名女性），结果应在一到两天内可得（87.7%；115名女性）。检测的侵入性不应超过阴道检查（85.4%；112名女性）。检测重复次数不应超过两次（96.1%；125名女性），结果应至少在六个月经周期内有用（89.3%；117名女性）。给予子宫内膜的重要性评分与检测付费意愿弱相关；然而，没有证据表明这种相关性不同于0（肯德尔tau系数=0.1101765，z=1.4327，p值=0.1519；斯皮尔曼等级相关系数=0.1268444，S=327136，p值=0.1488）。
女性了解子宫内膜对成功妊娠所起的重要作用，并且她们对检测的指征、时间、侵入性、检测重复需求、结果有效性和检测成本有特定看法。
