腹腔镜卵巢子宫内膜瘤切除术后卵巢内注射富血小板血浆(PRP)对卵巢的保护作用:一项随机对照试验。

IF 1.9 Q2 OBSTETRICS & GYNECOLOGY
Samaneh Rokhgireh, Fereshteh Rahimi, Neda Eslahi, Roya Derakhshan, Arash Mohazzab
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引用次数: 0

摘要

目的:本研究旨在评价富血小板血浆(PRP)在子宫内膜异位症行腹腔镜膀胱切除术患者保留卵巢储备中的作用。方法:采用随机、平行、开放标签的II期临床试验。共有38名年龄在20 - 35岁的符合条件的卵巢子宫内膜异位瘤女性,作为腹腔镜卵巢囊肿切除术的候选人,被随机分配到PRP组(n = 20)和对照组(n = 18)。PRP组在膀胱切除术后立即卵巢内注射2- 4cc PRP,而对照组在没有额外干预的情况下进行膀胱切除术。主要结果是干预后6个月血清抗勒氏杆菌激素(AMH)水平的变化。次要结果是干预后6个月的心房卵泡计数(AFC)。术后48小时内监测短期不良反应。结果:PRP组AMH水平变化可忽略不计(平均差异0.05,95% CI: -0.17 ~ 0.26),而对照组AMH水平明显下降(平均差异- 0.24,95% CI: -0.5 ~ 0.12)。组间校正后平均差异为- 0.308(-0.626 ~ -0.01),有统计学意义(P = 0.057)。两组间AFC无显著差异,无短期不良事件报告。结论:这项II期探索性试验发现子宫内膜瘤手术后卵巢内PRP注射对AMH水平的保存有接近显著的趋势。虽然这些发现不是决定性的,但它们支持了该方法的可行性和安全性,值得在更大规模的对照试验中进一步评估。试验注册:该研究已于2021年12月1日在伊朗临床试验注册中心前瞻性注册,编号为IRCT20191123045476N3 (https://irct.behdasht.gov.ir/trial/58688)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ovario-protective effect of intra-ovarian injection of platelet rich plasma (PRP) after laparoscopic cystectomy of ovarian endometrioma: a randomized control trial.

Objective: This study aimed to evaluate the effectiveness of Platelet-Rich Plasma (PRP) in preserving ovarian reserve in patients with endometriosis who underwent laparoscopic cystectomy.

Method: A randomized, parallel, open-label phase II clinical trial was conducted. A total of 38 eligible women aged 20 to 35 years with ovarian endometrioma, candidates for laparoscopic ovarian cystectomy, were randomly assigned to either the PRP group (n = 20) or the control group (n = 18). The PRP group received an intra-ovarian injection of 2-4 cc of PRP immediately after cystectomy, while the control group underwent cystectomy without additional intervention. The primary outcome was the change in serum anti-Müllerian hormone (AMH) levels six months post-intervention. The secondary outcome was the antral follicle count (AFC) six months post-intervention. Short-term adverse effects were monitored within the first 48 h after the procedure.

Results: The PRP group showed a negligible change in AMH levels (mean difference 0.05, 95% CI: -0.17 to 0.26), while the control group exhibited a significant decline (mean difference - 0.24, 95% CI: -0.5 to 0.12). The adjusted mean difference between the groups was - 0.308 (-0.626 to -0.01), tending toward statistical significance (P = 0.057). No significant differences in AFC were observed between the groups, and no short-term adverse events were reported.

Conclusions: This phase II exploratory trial found a near-significant trend toward preservation of AMH levels with intra-ovarian PRP injection after endometrioma surgery. While these findings are not definitive, they support the feasibility and safety of the approach and warrant further evaluation in larger, controlled trials.

Trial registration: The study was prospectively registered in the Iranian Registry of Clinical Trials under the number IRCT20191123045476N3 on December 1, 2021 ( https://irct.behdasht.gov.ir/trial/58688 ).

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