Department of Obstetrics and Gynaecology, Leuven University Fertility Centre, University Hospitals Leuven, Leuven 3000, Belgium.
Department of Development and Regeneration, KU Leuven, Leuven 3000, Belgium.
Hum Reprod. 2021 Feb 18;36(3):636-646. doi: 10.1093/humrep/deaa346.
Can the Endometriosis Fertility Index (EFI) be estimated accurately before surgery?
The EFI can be estimated accurately based on mere clinical/ultrasound information, with some improvement after adding data from diagnostic laparoscopy.
The EFI is a validated clinical instrument predicting the probability of pregnancy after endometriosis surgery without the use of ART. Being an end-of-surgery-score, it implies the decision for operative laparoscopy to be made in advance-hence, its role in the pre-surgical decision-making process remains to be established.
STUDY DESIGN, SIZE, DURATION: Single-cohort prospective observational study in 82 patients undergoing complete endometriosis excision (between June and December 2016). Two methods were used to estimate the final EFI: type A based on non-surgical clinical/ultrasound findings only, and type B based on the combination of non-surgical clinical/ultrasound findings and diagnostic laparoscopy data. To calculate EFI type A, an algorithm was created to translate non-surgical clinical/imaging information into rASRM (revised American Society of Reproductive Medicine)-and EFI points. EFI type A and type B estimates were assessed for their clinical and numerical agreement with the final EFI score. Agreement was defined as clinical if EFI scores were within the same range (0-4, 5-6, 7-10), and numerical if their difference was ≤1.
PARTICIPANTS/MATERIALS, SETTING, METHODS: All 82 patients underwent complete laparoscopic CO2-laser excision of any rASRM stage of endometriosis in the Leuven University Fertility Centre (LUFC) of University Hospitals Leuven, a tertiary referral centre for both endometriosis and infertility. An anonymized clinical research file was created. For each patient, three different data sets were created, in order to allow the estimation of the (surgical part) EFI and of the rASRM scores, defined as follows: 'Estimated type A' contained only non-surgical clinical/imaging data, 'Estimated type B' included type A information plus the information of the diagnostic laparoscopy and 'Final EFI' included information of type A, type B and all intra-operative information required to calculate the final EFI. To calculate EFI type A without surgical information, a set of rules was used to translate pre-surgical clinical/imaging information into (rASRM and EFI points). Scoring was done by one person (C.T.), with a time interval of 4 weeks between sessions for each EFI type. Next to the EFI, also rASRM score and stage were calculated.
Agreement rate between estimated EFI type A and final EFI was high for both the clinical (0.915; 95% CI 0.832-0.965) and numerical definition (0.878; 95% CI 0.787-0.940). Agreement rates between estimated EFI type B and final EFI were even higher (clinical (0.988; 95% CI 0.934-1.000), numerical (0.963; 95% CI 0.897-0.992)).
LIMITATIONS, REASONS FOR CAUTION: Type A estimation is dependent on high-level gynaecological ultrasound expertise, which may not be available in all clinics. A small number of patients had no prior clinical, ultrasound (hard markers) or surgical confirmation of the diagnosis of endometriosis. When applying the estimated EFI type A in clinical practice, a priori assumptions of the presence or absence of endometriosis will need to be made in adjunct to the estimation of the estimated type A EFI when counselling patients on the potential benefit of an (at least diagnostic) laparoscopy. The level of agreement for type A or B should also be taken into account when counselling patients on the type of efforts undertaken to attempt to diagnose or rule out endometriosis.
As this study reports, the EFI can be estimated accurately based on clinical/ultrasound data only without the need for any surgical data. This means that the EFI could be used as an instrument to guide joint physician-patient decision-making between surgery, ART or other fertility management options for the individualized treatment of women with endometriosis-related infertility.
STUDY FUNDING/COMPETING INTEREST(S): During this study period, C.T. was supported by FWO (Research Fund Flanders, Grant number 1700816N) and UZ Leuven KOF (University Hospitals Leuven, Klinisch Onderzoeksfonds).The LUFC received unrestricted research grants from Ferring Pharmaceuticals and Merck SA. Gedeon Richter and MSD sponsored travel to and attendance at scientific meetings. C.M. received consultancy fees from Lumenis (paid to KU Leuven, no private revenue). T.D. has been vice-president and head of global medical affairs infertility for the multinational pharmaceutical company Merck (Darmstadt, Germany) since 1 October 2015. He continues his academic appointment on a part-time basis as Professor of Reproductive Medicine at the University of Leuven (KU Leuven). T.D. has been vice-president and head of global medical affairs infertility for the multinational pharmaceutical company Merck (Darmstadt, Germany) since October 2015. He is also a Guest Professor in Reproductive Medicine and Biology at the Department of Development and Regeneration, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium, and an Adjunct Professor at the Department of Obstetrics and Gynecology in the University of Yale, New Haven, USA. This work was initiated before he joined Merck KGaA in October 2015, and completed during the subsequent years.
study registration number at UZ Leuven Clinical Trial Centre: S59221.
在手术前能否准确估计子宫内膜异位症生育指数（EFI）？
仅根据临床/超声信息即可准确估计 EFI，在添加诊断性腹腔镜检查数据后可有所改善。
EFI 是一种经过验证的临床工具，可预测在不使用 ART 的情况下进行子宫内膜异位症手术后的妊娠概率。作为手术结束时的评分，这意味着需要提前做出进行腹腔镜手术的决定——因此，其在手术前决策过程中的作用仍有待确定。
研究设计、规模、持续时间：对 2016 年 6 月至 12 月期间在 82 名接受完全子宫内膜异位症切除术的患者进行了单队列前瞻性观察性研究。使用两种方法估计最终的 EFI：基于非手术临床/超声检查结果的 A 型，以及基于非手术临床/超声检查结果和诊断腹腔镜检查数据的 B 型。为了计算 EFI 型 A，创建了一个算法将非手术临床/成像信息转换为 rASRM（修订后的美国生殖医学学会）和 EFI 点。评估 EFI 型 A 和 B 的估计值与最终 EFI 评分的临床和数值一致性。如果 EFI 评分在同一范围内（0-4、5-6、7-10），则定义为临床一致，如果差异≤1，则定义为数值一致。
参与者/材料、设置、方法：所有 82 名患者均在鲁汶大学附属医院（鲁汶大学医院）的 Leuven 大学生育中心（LUFC）接受完全腹腔镜 CO2-激光切除任何 rASRM 阶段的子宫内膜异位症，该中心是子宫内膜异位症和不孕症的三级转诊中心。创建了一个匿名的临床研究文件。为每位患者创建了三个不同的数据集，以便可以估计（手术部分）EFI 和 rASRM 评分，定义如下：“估计的 A 型”仅包含非手术临床/成像数据，“估计的 B 型”包含 A 型信息加上诊断腹腔镜检查信息，“最终 EFI”包含 A 型、B 型和所有术中信息，这些信息是计算最终 EFI 所必需的。为了在没有手术信息的情况下计算 EFI 型 A，使用一组规则将术前临床/成像信息转换为（rASRM 和 EFI 点）。评分由一个人（C.T.）进行，每个 EFI 类型之间间隔 4 周进行一次。除了 EFI 之外，还计算了 rASRM 评分和分期。
估计的 EFI 型 A 与最终 EFI 的临床（0.915；95%CI 0.832-0.965）和数值定义（0.878；95%CI 0.787-0.940）之间的一致性率很高。估计的 EFI 型 B 与最终 EFI 的一致性率甚至更高（临床（0.988；95%CI 0.934-1.000），数值（0.963；95%CI 0.897-0.992））。
局限性、谨慎的原因：类型 A 的估计取决于高水平的妇科超声专业知识，而并非所有诊所都具备。一小部分患者没有先前的临床、超声（硬指标）或手术确认子宫内膜异位症的诊断。在临床实践中应用估计的 EFI 型 A 时，在向患者咨询进行（至少是诊断性）腹腔镜检查的潜在益处时，需要预先假设是否存在子宫内膜异位症。在向患者咨询用于诊断或排除子宫内膜异位症的努力类型时，还应考虑 A 型或 B 型的一致性水平。
正如本研究报告的那样，可以仅根据临床/超声数据准确估计 EFI，而无需任何手术数据。这意味着 EFI 可以用作指导医生-患者共同决策的工具，以便在手术、ART 或其他生育管理选择之间进行选择，以个体化治疗患有子宫内膜异位症相关不孕症的女性。
研究资金/利益冲突：在研究期间，C.T. 得到了 FWO（佛兰德研究基金，编号 1700816N）和 UZ Leuven KOF（鲁汶大学医院，临床研究基金）的支持。LUFC 从 Ferring 制药公司和默克公司获得了无限制的研究赠款。Gedeon Richter 和 MSD 赞助旅行和参加科学会议。C.M. 从 Lumenis（支付给 KU Leuven，没有私人收入）获得咨询费。T.D. 自 2015 年 10 月 1 日起担任跨国制药公司默克（德国达姆施塔特）的全球医学事务部主任和生育领域负责人。他继续以兼职的形式在鲁汶大学（鲁汶大学）担任生殖医学教授。T.D. 自 2015 年 10 月 1 日起担任跨国制药公司默克（德国达姆施塔特）的全球医学事务部主任和生育领域负责人。他还是比利时鲁汶大学发展与再生系生殖医学和生物学客座教授（鲁汶大学）和美国耶鲁大学妇产科兼职教授。这项工作是在他于 2015 年 10 月加入默克 KGaA 之前开始的，并且在随后的几年中完成了。
在 UZ Leuven 临床试验中心的研究注册编号：S59221。
