Objective

To analyze the impact on live birth rates (LBRs) of the individualized luteal phase support (termed iLPS) in patients with low serum progesterone (P) levels compared with patients without iLPS.

Design

Retrospective cohort study, December 1, 2018, to May 30, 2019.

Setting

Private medical center.

Patient(s)

A total of 2,275 patients checked for serum P on the day of blastocyst transfer were analyzed. During the study period, 1,299 patients showed serum P levels of ≥9.2 ng/mL, whereas 550 showed serum P levels of <9.2 ng/mL and received iLPS. Additionally, a historical group of 426 patients with serum P levels of <9.2 ng/mL but no iLPS were used for comparison.

Eligible patients were aged ≤50 years with adequate endometrium morphology after receiving estrogens. Luteal phase support was provided with micronized vaginal P (MVP) to all women. Patients with personalized initiation of exogenous P according to the endometrial receptivity assay test, polyps, fibroids distorting the cavity, or hydrosalpinx were not included in the analysis.

Intervention(s)

As routine practice since December 2018, patients with low serum P levels received an iLPS with a daily injection of 25 mg of subcutaneous P from the day of embryo transfer (ET) in addition to standard LPS (400 mg of MVP twice a day).

Main Outcome Measure(s)

Live birth rate.

Result(s)

The LBR was 44.9% in the iLPS cases vs. 45.0% in patients with normal serum P levels (crude odds ratio [OR], 1.0; 95% confidence interval [CI], 0.82–1.22). By regression analysis, low serum P levels did not affect the LBR after adjusting for possible confounders (age, oocyte origin, fresh vs. frozen, day of ET, embryo quality, number of embryos transferred) (adjusted OR, 0.99; 95% CI, 0.79–1.25). Similarly, no differences were observed in other pregnancy outcomes between groups.

The LBR was significantly higher in the group of patients who received additional subcutaneous P (iLPS) compared with the historical group with low serum P levels and no iLPS (44.9% vs. 37.3%; OR, 1.37; 95% CI, 1.06–1.78).

In the overall population, patients showing P levels of <9.2 ng/mL on the day of ET were slightly younger and had higher body mass index and lower estradiol and P levels during the proliferative phase compared with patients with P levels of ≥9.2 ng/mL. No differences were observed with regard to the time in between the last dose of MVP and the serum P determination. After a multivariable logistic regression analysis, only body mass index and estradiol levels in the proliferative phase reminded statistically significant.

Significant differences in the LBR were observed between patients with serum P levels of <9.2 ng/mL without iLPS and patients with serum P levels of ≥9.2 ng/mL when using either own or donated oocytes.

Conclusion(s)

Individualized LPS for patients with low serum P levels produces LBRs similar to those of patients with adequate serum P levels.

中文翻译：

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个体化黄体期支持使人工子宫内膜准备周期中孕酮水平低的女性在胚胎移植当天的活产率正常化

客观的

与没有 iLPS 的患者相比，分析低血清孕酮 (P) 水平的患者个体化黄体期支持 (称为 iLPS) 对活产率 (LBR) 的影响。

设计

回顾性队列研究，2018 年 12 月 1 日至 2019 年 5 月 30 日。

环境

私人医疗中心。

耐心）

分析了在囊胚移植当天检查血清 P 的总共 2,275 名患者。在研究期间，1,299 名患者的血清 P 水平≥9.2 ng/mL，而 550 名患者的血清 P 水平 <9.2 ng/mL 并接受了 iLPS。此外，历史组 426 名血清 P 水平 <9.2 ng/mL 但没有 iLPS 的患者用于比较。

符合条件的患者年龄≤50 岁，接受雌激素治疗后具有足够的子宫内膜形态。向所有女性提供黄体期支持和微粉化阴道 P (MVP)。根据子宫内膜容受性试验、息肉、子宫肌瘤扭曲腔或输卵管积水，个体化启动外源性 P 的患者不包括在分析中。

干预措施

自 2018 年 12 月以来，作为常规做法，血清 P 水平低的患者除了标准 LPS（每天两次 400 mg MVP）外，还接受了 iLPS，从胚胎移植（ET）之日起每天注射 25 mg 皮下 P。

主要观察指标）

活产率。

结果）

iLPS 病例的 LBR 为 44.9%，而血清 P 水平正常的患者为 45.0%（粗比值比 [OR]，1.0；95% 置信区间 [CI]，0.82-1.22）。通过回归分析，在调整可能的混杂因素（年龄、卵母细胞来源、新鲜与冷冻、ET 天数、胚胎质量、移植的胚胎数量）后，低血清 P 水平不影响 LBR（调整后的 OR，0.99；95% CI , 0.79–1.25)。同样，组间的其他妊娠结局也没有观察到差异。

与血清 P 水平低且无 iLPS 的历史组相比，接受额外皮下 P (iLPS) 的患者组的 LBR 显着更高（44.9% 对 37.3%；OR，1.37；95% CI，1.06-1.78 ）。

在整个人群中，与 P 水平≥9.2 ng/mL 的患者相比，ET 当天 P 水平 <9.2 ng/mL 的患者年龄稍小，在增殖期体重指数较高，雌二醇和 P 水平较低。毫升。在最后一剂 MVP 和血清 P 测定之间的时间方面没有观察到差异。经过多变量逻辑回归分析，只有增殖期的体重指数和雌二醇水平具有统计学意义。

在使用自有或捐赠卵母细胞时，血清 P 水平 <9.2 ng/mL 且未使用 iLPS 的患者与血清 P 水平≥9.2 ng/mL 的患者之间的 LBR 存在显着差异。

结论

血清 P 水平低的患者的个体化 LPS 产生的 LBR 与血清 P 水平充足的患者相似。