Miriello Donatella, Galanti Francesco, Meneghini Caterina, Fabiani Cristina, Dal Lago Alessandro, Schiavi Michele C, Rago Rocco
Unit of Reproductive Physiopathology and Andrology, Sandro Pertini Hospital, Rome, Italy -
Unit of Reproductive Physiopathology and Andrology, Sandro Pertini Hospital, Rome, Italy.
Minerva Obstet Gynecol. 2022 Apr;74(2):130-136. doi: 10.23736/S2724-606X.21.04731-X. Epub 2021 Apr 20.
Uterine fibroids are the most common benign tumor in women. According to literature, submucosal myomas have a negative effect on reproductive outcomes in women undergoing assisted reproductive techniques (ART) but there are fewer data concerning intramural fibroids. During last years, ulipristal acetate (UPA) 5 mg was widely used as medical option of fibroid's treatment, but from 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) has revoked the marketing authorization after some cases of liver toxicity.
In this observational, retrospective study we collected data from a sample of 23 women affected by symptomatic uterine fibroids (from type 1 to type 7 according FIGO classification) followed in our center for assisted reproduction from 2016-2019. All patients received 5 mg/day UPA for three months, followed by two months of wash-out therapy. A group of 13 women treated with UPA, with intramural fibroid not distorting the uterine cavity, after wash-out therapy, affected by tubal or idiopathic factors of infertility too, underwent ART. We also evaluated a control group of women, not affected by fibroids, randomly selected from a general group of our ART patients, similar by age, BMI, and cause of infertility only idiopathic or tubal factors. We evaluated the impact of UPA on reduction of fibroid volume, symptomatology and distortion of the cavity in all the women treated, and the IVF (in-vitro fertilization) outcome between the fibroid group of women affected by intramural fibroids who underwent ART, and the control group.
In all the women treated with UPA the overall median fibroid volume pretreatment was 45.168±35.360 mm, that decreased to a mean value of 22.592±22.116 mm3 post one cycle of UPA, with an overall mean decrease of -22.586 mm (of 49%) statistically significant (P=0.00001). After treatment, the distortion of the uterine cavity reduced in high percentage of cases: 85,71% (type 1-2), χ difference in respect to the value pretreatment of 0.3941, and 86.96% of patients subjectively referred an improvement in the symptomatology. In the group of 13 women that undergone ART, after one IVF cycle for each patient, we obtained 61% of positivity of dosage of beta human chorionic gonadotropin (hCG) after UPA treatment, and we obtained a similar value in the control group.
In our little sample we have observed that UPA represented a valid non-invasive medical treatment strategy for fibroids in women candidate for (IVF, not only in women affected by sub-mucosal, but also by intramural fibroids not distorting uterine cavity. After a single, three months course of treatment, we obtained good results in terms of reduction of fibroid's volume and improvement of symptomatology, without side effects, preparing a more favorable environment for ART.
子宫肌瘤是女性最常见的良性肿瘤。据文献报道,黏膜下肌瘤对接受辅助生殖技术(ART)的女性的生殖结局有负面影响,但关于肌壁间肌瘤的数据较少。在过去几年中,5毫克醋酸乌利司他(UPA)被广泛用作子宫肌瘤治疗的药物选择,但自2020年起,药物警戒风险评估委员会(PRAC)在出现一些肝毒性病例后撤销了其上市许可。
在这项观察性回顾性研究中,我们收集了2016年至2019年在我们中心接受辅助生殖治疗的23例有症状子宫肌瘤患者(根据FIGO分类为1型至7型)的数据。所有患者接受5毫克/天的UPA治疗三个月,随后进行两个月的洗脱期治疗。一组13例接受UPA治疗且肌壁间肌瘤未使子宫腔变形的女性,在洗脱期治疗后,也受输卵管或特发性不孕因素影响,接受了ART。我们还评估了一组未患子宫肌瘤的女性作为对照组,她们是从我们ART患者的总体中随机选取的,在年龄、BMI以及不孕原因(仅为特发性或输卵管因素)方面相似。我们评估了UPA对所有接受治疗女性的肌瘤体积缩小、症状以及子宫腔变形的影响,以及接受ART的肌壁间肌瘤女性肌瘤组与对照组之间的体外受精(IVF)结局。
在所有接受UPA治疗的女性中,治疗前肌瘤总体中位体积为45.168±35.360立方毫米,在一个UPA疗程后降至平均值22.592±22.116立方毫米,总体平均减少-22.586立方毫米(49%),具有统计学意义(P=0.00001)。治疗后,子宫腔变形在高比例病例中减少:85.71%(1 - 2型),与治疗前值的χ差异为0.3941,86.96%的患者主观表示症状有所改善。在接受ART的13名女性组中,每位患者经过一个IVF周期后,UPA治疗后β人绒毛膜促性腺激素(hCG)剂量阳性率为61%,我们在对照组中获得了类似的值。
在我们的小样本中,我们观察到UPA是一种有效的非侵入性药物治疗策略,适用于适合IVF的子宫肌瘤女性,不仅适用于黏膜下肌瘤患者,也适用于未使子宫腔变形的肌壁间肌瘤患者。经过一个为期三个月的单一疗程治疗后,我们在肌瘤体积缩小和症状改善方面取得了良好效果,且无副作用,为ART创造了更有利的环境。