结肠直肠子宫内膜异位症手术切除与 ART 治疗方案(TOSCA 研究)的(成本)效益对比研究方案。

Rozemarijn de Koning, Astrid E. P Cantineau, Karin van der Tuuk, B. De Bie, Henk Groen, M. E. van den Akker-van Marle, A. Nap, J. W. Maas, Frank Willem Jansen, A. Twijnstra, M. Blikkendaal
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引用次数: 0

摘要

目前,提高结直肠子宫内膜异位症和不孕症患者怀孕和活产几率的最佳治疗方法尚不清楚。有证据表明,手术和体外受精(IVF)或卵胞浆内单精子显微注射(ICSI)都能有效提高这些妇女的活产率(LBR)。然而,现有的证据质量不高,报告的结果差异很大,缺乏对两种治疗方案的直接比较,也没有评估与单纯的体外受精/卵胞浆内单精子显微注射治疗相比,综合策略是否能提高活产率。此外,治疗轨迹中的最佳手术时机仍不明确。TOSCA研究的首要目标是评估手术治疗(可能与IVF/ICSI联合使用)与单纯IVF/ICSI治疗相比,在提高结直肠子宫内膜异位症和不孕症患者持续妊娠导致活产的几率方面的有效性,衡量标准是累积LBR。次要目标是评估和比较两组患者的生活质量和成本效益。患者将在纳入研究后接受 40 个月的随访,直至活产。TOSCA研究预计将在6年内完成。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The (cost-) effectiveness Of Surgical excision of Colorectal endometriosis compared to ART treatment trAjectory (TOSCA study) - a study protocol.
Currently, the optimal treatment to increase the chance of pregnancy and live birth in patients with colorectal endometriosis and subfertility is unknown. Evidence suggests that that both surgery and in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) are effective in improving live birth rate (LBR) among these women. However, the available evidence is of low quality, reports highly heterogeneous results, lacks direct comparison between both treatment options and does not assess whether a combination strategy results in a higher LBR compared to IVF/ICSI-only treatment. Additionally, the optimal timing of surgery within the treatment trajectory remains unclear. The primary objective of the TOSCA study is to assess the effectiveness of surgical treatment (potentially combined with IVF/ICSI) compared to IVF/ICSI-only treatment to increase the chance of an ongoing pregnancy resulting in a live birth in patients with colorectal endometriosis and subfertility, measured by cumulative LBR. Secondary objectives are to assess and compare quality of life and cost-effectiveness in both groups. Patients will be followed for 40 months after inclusion or until live birth. The TOSCA study is expected to be completed in 6 years.
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