辅助生殖技术中阴道局部给药黄体支持方案中血清低孕酮水平的临床疗效研究

A clinical study on the level of serum low progesterone about luteal phase support for partial vaginal delivery in assisted reproductive technology

目的探讨辅助生殖技术(ART)中阴道局部给药的黄体支持方案血清低孕酮(P)水平对临床疗效的影响。方法选取2012年6月—2016年12月期间行激素替代方案冻融胚胎移植(FET)的624个周期,按照移植后黄体支持方案的不同分为A组(黄体酮阴道缓释凝胶+地屈孕酮组,348个周期)和B组(黄体酮针剂+地屈孕酮组,276个周期),比较组间、组内移植14 d妊娠与非妊娠者的血清P水平及妊娠结局。结果 (1)移植14 d A组中妊娠者与非妊娠者血清P水平无统计学差异(P>0.05),B组中妊娠者血清P水平[(74.08±24.80)nmol/L]明显高于非妊娠者[(62.28±29.34)nmol/L],差异有统计学意义(P<0.05)。(2)A组妊娠者的P水平[(16.07±9.40)nmol/L]明显低于B组,差异有统计学意义(P<0.05)。(3)胚胎着床率、临床妊娠率、早期流产率、异位妊娠率组间无统计学差异(P>0.05)。结论黄体酮阴道缓释凝胶作为黄体支持应用于胚胎移植术后,与肌肉注射黄体酮具有相似的临床疗效,但由于其具有子宫首过效应,血清中表达水平低,无需进行血清P水平的监测。

Objective To investigate the effects of low progesterone levels on the clinical efficacy of the luteal support protocol by using vaginal progesterone gel in assisted reproductive technology （ART）. Methods A total of 624 cycles of frozen-thawed embryo transfer （FET） with hormone replacement were performed in our center from June 2012 to December 2016. They were divided into two groups according to the difference in the post luteal support protocol： group A （progesterone vaginal sustained release gel ＋ dydrogesterone） 348 cycles and group B （progesterone injection ＋ dydrogesterone） 276 cycles. The serum progesterone levels and pregnancy outcome were compared in the two groups of pregnant and noli-pregnant women with 14 d after embryo transfer. Results 1） There were no significant differences in serum progesterone levels between the pregnant and non- pregnant groups in group A after 14 d of transplantation （P〉0.05）. The level of serum progesterone in group B [（74.08±24.80）nmol/L] was significantly higher than that of non-pregnant women [（62.28±29.34 ） nmol/L] after 14 d of Iransplantation, and the difference was statistically significant （P〈0.05）. 2） The progesterone level in group A [（16.07±9.40） nmol/L] was significantly lower than that in group B, the difference was statistically significant （P〈0.05）. 3） The rate of embryo implantation, the rate of clinical pregnancy, the rate of early abortion and the rate of ectopic pregnancy were not statistically different between the two groups （P〉0.05）. Conclusion Progesterone vaginal sustained-release gel as a luteal support in thetreatment of embryo transfer, has the same efficacy with intramuscular progesterone injection. But because it has the first-pass effect of uterus, the expression level in serum is low, so the monitoring of serum progesterone level is not needed.