Streuli I, Ramyead L, Silvestrini N, Petignat P, Dubuisson J
Department of Paediatrics, Gynaecology and Obstetrics, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
Hum Reprod. 2025 Jul 1;40(7):1305-1314. doi: 10.1093/humrep/deaf070.
Does definitive occlusion of uterine arteries have a short- or long-term impact on ovarian reserve markers in reproductive-age women undergoing laparoscopic myomectomy?
Preventive definitive uterine artery occlusion (UAO) during laparoscopic myomectomy reduces intraoperative blood loss but does not impact serum AMH levels after short- and long-term follow-up in reproductive-age women.
Uterine leiomyomas are the most common benign tumours in women of reproductive age. For symptomatic women willing to retain their uterus, especially for a future pregnancy, the current gold standard is surgical myomectomy for subserous/intramural leiomyoma. Temporary or definitive occlusion of uterine arteries can be performed to control bleeding during surgery but its impact on ovarian reserve markers is still unclear. A single randomized trial with a 1-year follow-up demonstrated that temporary bilateral UAO during laparoscopic myomectomy slightly decreased AMH levels at postoperative day 2 but has no significant impact at 3, 6, and 12 months after surgery.
STUDY DESIGN, SIZE, DURATION: We conducted a randomized controlled trial with a 2-year follow-up evaluating the effect of definitive occlusion of uterine arteries on ovarian reserve markers via sequential measures of AMH levels and AFC by ultrasound assessment. The study included 58 women with symptomatic leiomyoma type FIGO 3 to 6 scheduled for laparoscopic myomectomy between July 2015 and October 2021. Patient allocation was disclosed to the surgeon just before starting the procedure; women were blinded to group allocation throughout the study.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients were randomized in two groups: the UAO group (laparoscopic myomectomy with preventive occlusion of uterine arteries) (n = 29 women) and the no-UAO group (laparoscopic myomectomy without occlusion of uterine arteries but with intra-myometrial injection of vasoconstrictive agents) (N = 29 women). Serum AMH levels and AFC were evaluated at baseline (T0) and followed at 1 month (T1), 3 months (T3), 6 months (T6), 12 months (T12), and 24 months (T24) after surgery. Intraoperative blood loss, evolution of uterine bleeding and pain symptoms, and leiomyoma recurrence were also evaluated as secondary outcomes. Pregnancies and live births were monitored.
Women in both groups did not differ in their baseline characteristics in terms of age, body mass index, ethnicity, parity, wish to become pregnant, hormonal treatment, leiomyoma number and size, baseline haemoglobin levels, uterine bleeding symptoms, baseline serum AMH levels, and AFC. The mean operative time was similar between both groups. Mean blood loss during surgery was on average 138 (±104) ml in the UAO group versus 436 (±498) ml in controls (P < 0.001). In the UAO group, 0% had an intraoperative blood loss >500 ml versus 32.1% in the no-UAO group (P < 0.01). Regarding clinical symptoms, most patients in both groups had decreased menstrual flow at the last follow-up visit (24 months) compared to baseline and improvement of dysmenorrhea followed the same trend with a reduction in pain levels in both groups. The risk of leiomyoma recurrence was similar between both groups. Serum AMH levels did not differ between the groups at any time (T1, T3, T6, T12, and T24) and non-inferiority of preventive occlusion was demonstrated with a non-inferiority margin of [-3.5 pmol/l]. Differences between means and 95% CI (in parentheses) were as follows: at T1 -0.11 (-2.14 to 2.40), at T3 -0.25 (-2.36 to 2.21), at T6 0.81 (-2.69 to 3.84), at T12 -0.95 (-3.15 to 1.33), and at T24 1.18 (-1.95 to 3.82). AFC did not differ between the groups at any time, however, non-inferiority of preventive occlusion could not be demonstrated, presumably due to a large variability in this measurement.
LIMITATIONS, REASONS FOR CAUTION: Our sample size was calculated to detect a clinically relevant difference of at least two-thirds of the SD in serum AMH levels, but we cannot exclude that a larger sample size might have revealed a smaller impact on serum AMH.
Preventive UAO during laparoscopic myomectomy does not compromise ovarian reserve markers and can be used safely to improve perioperative bleeding control in women of reproductive age. Incorporating UAO as a preventive measure during laparoscopic myomectomy may enhance the safety of the procedure.
STUDY FUNDING/COMPETING INTEREST(S): Funded by the Department of Paediatrics, Gynecology and Obstetrics of the Geneva University Hospitals. There are no competing interests to declare.
NCT02563392.
9 July 2015.
DATE OF FIRST PATIENT’S ENROLMENT: July 2015.
对于接受腹腔镜子宫肌瘤切除术的育龄女性,子宫动脉的确定性闭塞对卵巢储备标志物是否有短期或长期影响?
在腹腔镜子宫肌瘤切除术中进行预防性子宫动脉闭塞(UAO)可减少术中失血,但在对育龄女性进行短期和长期随访后,对血清抗缪勒管激素(AMH)水平没有影响。
子宫平滑肌瘤是育龄女性最常见的良性肿瘤。对于有症状且希望保留子宫,尤其是未来有怀孕意愿的女性,目前对于浆膜下/肌壁间平滑肌瘤的金标准治疗方法是手术切除肌瘤。手术中可进行子宫动脉的临时或确定性闭塞以控制出血,但其对卵巢储备标志物的影响仍不明确。一项为期1年随访的单随机试验表明,腹腔镜子宫肌瘤切除术中进行临时双侧UAO在术后第2天会使AMH水平略有下降,但在术后3、6和12个月没有显著影响。
研究设计、规模、持续时间:我们进行了一项为期2年随访的随机对照试验,通过超声评估连续测量AMH水平和窦卵泡计数(AFC)来评估子宫动脉确定性闭塞对卵巢储备标志物的影响。该研究纳入了2015年7月至2021年10月期间计划进行腹腔镜子宫肌瘤切除术的58例FIGO 3至6型有症状平滑肌瘤女性。在手术开始前向外科医生披露患者分组情况;在整个研究过程中,女性对分组情况不知情。
参与者/材料、环境、方法:患者被随机分为两组:UAO组(进行预防性子宫动脉闭塞的腹腔镜子宫肌瘤切除术)(n = 29例女性)和非UAO组(不进行子宫动脉闭塞但进行肌层内注射血管收缩剂的腹腔镜子宫肌瘤切除术)(N = 29例女性)。在基线(T0)时评估血清AMH水平和AFC,并在术后1个月(T1)、3个月(T3)、6个月(T6)、12个月(T12)和24个月(T24)进行随访。术中失血、子宫出血和疼痛症状的演变以及平滑肌瘤复发也作为次要结果进行评估。监测妊娠和活产情况。
两组女性在年龄、体重指数、种族、产次、怀孕意愿、激素治疗、平滑肌瘤数量和大小、基线血红蛋白水平、子宫出血症状、基线血清AMH水平和AFC等基线特征方面没有差异。两组的平均手术时间相似。UAO组术中平均失血量为138(±104)ml,而对照组为436(±498)ml(P < 0.001)。在UAO组中,0%的患者术中失血量>500 ml,而非UAO组为32.1%(P < 0.01)。关于临床症状,与基线相比,两组大多数患者在最后一次随访(24个月)时月经量减少,痛经改善情况遵循相同趋势,两组疼痛水平均降低。两组平滑肌瘤复发风险相似。两组在任何时间(T1、T3、T6、T12和T24)的血清AMH水平均无差异,并且预防性闭塞的非劣效性在非劣效界值为[-3.5 pmol/l]时得到证实。均值差异及95%置信区间(括号内)如下:在T1时为-0.11(-2.14至2.40),在T3时为-0.25(-2.36至2.21),在T6时为0.81(-2.69至3.84),在T12时为-0.95(-3.15至1.33),在T时为1.18(-1.95至3.82)。两组在任何时间的AFC均无差异,然而,预防性闭塞的非劣效性未能得到证实,可能是由于该测量的变异性较大。
局限性、注意事项:我们计算的样本量是为了检测血清AMH水平至少三分之二标准差的临床相关差异,但我们不能排除更大的样本量可能会显示对血清AMH的影响更小。
腹腔镜子宫肌瘤切除术中进行预防性UAO不会损害卵巢储备标志物,可安全用于改善育龄女性围手术期的出血控制。在腹腔镜子宫肌瘤切除术中采用UAO作为预防措施可能会提高手术的安全性。
研究资金/利益冲突:由日内瓦大学医院儿科、妇科和产科资助。没有利益冲突需要声明。
NCT02563392。
2015年7月9日。
2015年7月。