OBJECTIVE

目的

Previous studies comparing the effects of Granulocyte Colony Stimulating Factor (GCSF) and Platelet Rich Plasma (PRP) on the outcomes of frozen embryo transfer (FET) have produced conflicting results due to the lack of formal randomized controlled trials (RCTs). This study aimed to investigate the impact of intrauterine infusion of GCSF and PRP on the clinical pregnancy rate and outcomes in women undergoing FET, as well as the effect of these interventions on the implantation rate, transvaginal ultrasound (TVUS) and Doppler findings, and histological assessment of the endometrium.

以往的研究比较了粒细胞集落刺激因子（GCSF）和富血小板血浆（PRP）对冷冻胚胎移植（FET）结果的影响，但由于缺乏正式的随机对照试验（RCTs），这些研究结果相互矛盾。本研究旨在探讨宫腔内输注GCSF 和 PRP对冷冻胚胎移植妇女的临床妊娠率和预后的影响，以及这些干预措施对植入率、经阴道超声（TVUS）和多普勒检查结果以及子宫内膜组织学评估的影响。

MATERIALS AND METHODS

材料与方法

This RCT included 390 women randomized equally to three arms receiving either 300 mcg GCSF, 1 ml PRP, or saline. The intervention was slowly infused into the uterine cavity using the intrauterine insemination catheter under ultrasound guidance. All women received conventional hormonal therapy before the FET cycle. The endometrium was evaluated by TVUS, Doppler, and histological assessment in both natural and intervention cycles. Before the transfer, a group of embryos were genetically tested using NGS techniques. The clinical pregnancy rate was determined by the presence of fetal heartbeat by TVUS after 6 weeks of embryo transfer. Pregnancy outcomes were followed up after pregnancy confirmations.

该研究包括390名妇女，她们被随机平均分为三组，分别接受300mcgGCSF、1ml PRP 或生理盐水。在超声引导下，使用宫腔内人工授精导管将干预药物缓慢注入宫腔。所有女性在 FET周期前都接受了常规激素治疗。对自然周期和干预周期的子宫内膜均进行了 TVUS、多普勒和组织学评估。移植前，使用二代测序（NGS）对一组胚胎进行了基因检测。胚胎移植6周后，通过 TVUS检查是否有胎心搏动来确定临床妊娠率。妊娠确认后，对妊娠结果进行随访。

RESULTS

结果

The clinical pregnancy rate did not differ significantly across the study arms (50.4% in GCSF, 51.2% in PRP, and 45.8% in placebo; P=0.66). PRP administration resulted in a significant improvement in endometrial vascularity compared to placebo (P=0.003). However, this change did not affect the clinical pregnancy rate, and all other endometrial variables showed no significant differences between the study arms. The live birth rate was comparable within the arms (72.5% in GCSF, 75.6% in PRP, and 76.9% in placebo; P=0.897). The pregnancy rate and outcome were still statistically non-significant when subgroup analyses were performed in women who had thin endometrium (<7 mm), women classified as poor-responders (antimullerian hormone <1), women who underwent preimplantation genetic screening using next-generation sequencing, or women who had recurrent implantation failure (≥3 times).

各研究组中，临床妊娠率在不同治疗方案之间没有显著差异（GCSF组为50.4%，PRP组为51.2%，安慰剂组为45.8%；P=0.66）。与安慰剂相比，PRP治疗显著改善了子宫内膜血流（P=0.003）。然而，这种改变并没有影响临床妊娠率，而且其他子宫内膜变量在不同治疗方案之间也没有显著差异。活产率在不同治疗组之间相当（GCSF组为72.5%，PRP组为75.6%，安慰剂组为76.9%；P=0.897）。当对子组进行分析时，对于子宫内膜薄（<7 mm）的妇女、AMH<1的妇女、使用二代测序进行胚胎植入前遗传筛查的妇女或反复植入失败（≥3次）的妇女，妊娠率和结果仍然没有统计学显著差异。

CONCLUSIONS

结论

This study demonstrates that neither GCSF nor PRP has an impact on the clinical pregnancy rate or pregnancy outcomes. Although PRP administration resulted in a significant improvement in endometrial vascularity, it did not affect the clinical pregnancy rate. Both interventions had comparable results with the infusion of saline.

本研究表明，GCSF 和 PRP 对临床妊娠率或妊娠结局均无影响。虽然PRP能显著改善子宫内膜血流，但并不影响临床妊娠率。与生理盐水输注相比，这两种干预措施的效果相当。

IMPACT STATEMENT

影响声明

Intrauterine infusion of GCSF and PRP had no impact on pregnancy determinants, rates, or outcomes. The improvement in endometrial vascularity found post-PRP infusion did not translate into a higher clinical pregnancy rate or better pregnancy outcomes. Both interventions had similar results to saline infusion.

宫腔内输注GCSF和 PRP 对妊娠决定因素、妊娠率或妊娠结局没有影响。PRP 输注后子宫内膜血管的改善并没有转化为更高的临床妊娠率或更好的妊娠结局。两种干预方法的效果与生理盐水输注相似。

文章来源：

PLATELET-RICH PLASMA AND COLONY-STIMULATING FACTOR ARE NON SUPERIOR TO PLACEBO IN IMPROVING ENDOMETRIAL QUALITY DURING FROZEN EMBRYO ICSI CYCLES - A DOUBLE-BLIND RCT Elbanna, Wael Saad et al.Fertility and Sterility, Volume 120, Issue 4, e19

Tags： 宫内灌注GCSF 和 PRP，对冻胚移植妊娠率无影响？