中度或严重子宫内膜异位症患者的妊娠结局如何？

Study question

研究问题

What are the pregnancy outcomes for women with moderate or severe endometriosis who are trying to conceive?

中度或严重子宫内膜异位症患者的妊娠结局如何？

Summary answer

摘要回答

Preliminary pregnancy rates in women with moderate/severe endometriosis are 11% for natural conception cycles and 22% for ART cycles. This is consistent with previous literature.

中/重度子宫内膜异位症女性的初次妊娠率：自然受孕周期为11% , ART周期为22% ，这与以前的文献一致。

What is known already

已知的是

Endometriosis is associated with reduced pregnancy rates in women attempting both spontaneous and assisted conception. Monthly fecundity is approximately half that of women without endometriosis and reduces further with increasing severity of disease. At present, the effect of surgery on the fertility outcomes of women with moderate or severe endometriosis remains unanswered. Treatment decisions are complex, particularly in those without pain symptoms seeking to optimise fertility outcomes.

自然妊娠和辅助妊娠的女性妊娠率降低与子宫内膜异位症有关。每月受孕率大约是无子宫内膜异位症女性的一半，并随着疾病的严重程度的增加而进一步降低。目前，外科手术对中度或重度子宫内膜异位症妇女的生育能力的影响仍未得到解答。治疗决策是复杂的，特别是在那些没有疼痛症状以寻求优化生育结果的患者。

Study design, size, duration

研究设计、规模、持续时间

ELFS is a prospective multi-site longitudinal cohort study being conducted over 5-years. This interim report summarises data from August 2021-January 2024 in participants <38 years with evidence of in-situ moderate or severe endometriosis desiring fertility immediately or in the future. ELFS prospectively measures and compares monthly clinical pregnancy and live birth rates in women having either surgical or conservative management of endometriosis. This report assesses outcomes for those trying to conceive naturally or with ART.

ELFS是一项前瞻性的多站点纵向队列研究，为期5年。本报告总结了2021年8月至2024年1月小于38岁的参与者数据，有证据表明中度或重度子宫内膜异位症希望立即或未来生育。ELFS前瞻性地衡量和比较了接受手术或保守治疗的子宫内膜异位症的女性的每月临床妊娠率和活产率。这份报告比较分析了自然妊娠或辅助生育技术妊娠患者的结果。

Participants/materials, setting, methods

参与者/材料、设置、方法

Following consent and baseline questionnaire completion, participants install the purpose-built ELFS App to their mobile phone or use a web-based option to complete cyclical surveys. The timing of surveys is dependent on a learned logic within the App and based on menstrual cycle length and pregnancy status. Participants report attempted conception cycles and any ART treatments undertaken with IVF or intrauterine insemination (IUI). Pregnancy outcomes are recorded as well as surgery during the study period.

在获得同意和基本问卷调查后，参与者需要在他们的手机上安装ELFS应用程序，或使用基于web选项来完成周期性调查。调查的时间取决于在应用程序中习得性逻辑，并基于月经周期长度和妊娠状态。参与者报告尝试受孕周期和任何采用体外受精或宫内授精（ IUI ）。在研究期间，同外科手术一样还记录了妊娠结局。

Main results and the role of chance

主要结果和角色机会

There are 124 participants enrolled in ELFS, 86 (69%) are in the surgical cohort and 38 (31%) in the conservative cohort. There are 45 participants (36%) who have indicated they are actively trying to conceive during the study and a total of 171 cycles have been recorded from these participants. Of those trying to conceive, 24 (53%) have elected to have surgery during the study period, compared to 23 (29%) who were not trying to conceive. The study has captured 126 cycles with attempted conception. Of these, 42 cycles (33%) utilised ART compared to 84 cycles (67%) of natural conception attempts. Of the ART cycles, 27 (75%) involved IVF with fresh or frozen embryo transfer and there were 9 (15%) IUI cycles. To date, there are 25 reported pregnancies. The pregnancy rate for ART cycles was 22% (8/36) compared to 11% (9/87) in the natural conception cycles. Of those who conceived following surgery, 47% (8/17) of pregnancies were following ART and 53% (9/17) were natural conceptions. There are 2 live births recorded, both from the cohort who had surgery during the study. A total of 5 miscarriages (20%) have been reported, 4 (80%) from the surgical cohort.

ELFS共纳入124例研究对象，手术组86例（69%），保守治疗组38例（31%）。其中有45名例（36%） 在研究期间积极备孕，总共记录了这些研究对象的171个周期。在研究期间，备孕对象中，24例（53%）选择了手术治疗，未备孕对象中，23例（29 %）选择了手术治疗。这项研究共收入了126个备孕周期。其中，42个（33%）ART周期，84个（67%）自然受孕周期。在ART周期中，有27个（75%）新鲜或冷冻胚胎移植的IVF周期，9个（15%） IUI周期。到目前为止，25例妊娠。ART周期的妊娠率为22%（8/36），自然周期为11%（9/87）。在手术后受孕的患者中，47%（8/17 ）接受ART，53%（9/17）自然受孕。有2例活产，都来自手术组。共报道了5例流产（20%），其中4例（80%）来自手术组。

Limitations, reasons for caution

局限性、谨慎原因

In the absence of data to guide management in this area, clinician scope of practice and concurrent pain symptoms are likely to influence recommendations for ART or surgery in those trying to conceive with moderate or severe endometriosis.

在缺乏数据指导管理的情况下，临床诊疗范围和并发疼痛症状可能会影响中度或重度子宫内膜症位症患者对ART或手术的建议。

Wider implications of the findings

研究结果的更广泛意义

This preliminary data is consistent with the current literature showing reduced natural and assisted conception rates in women with moderate or severe endometriosis. Long-term data will be required to determine if fertility and pregnancy outcomes are influenced by surgical management of endometriosis.

这一初步数据与目前的文献一致，显示中度或重度子宫内膜异位症降低患者的自然妊娠和辅助生殖妊娠受孕率。有关手术治疗对于子宫内膜异位症患者的生育能力和妊娠结局的影响, 需要长期的数据来确定。

参考文献：

V Ross, S Mooney, U Dior, C Reddington, C Cheng, M Amir, K Harlow, C Stern, P Rogers, M Healey, O-149 The Endometriosis Longitudinal Fertility Study (ELFS): Outcomes for women with moderate or severe endometriosis who are trying to conceive, Human Reproduction, Volume 39, Issue Supplement_1, July 2024, deae108.168, https://doi.org/10.1093/humrep/deae108.168