School of Medicine, Cheeloo College of Medicine, Shandong University, Jinan, China.
Department of Reproduction, Maternal and Child Health Hospital of Zoucheng, Zoucheng, China.
Front Endocrinol (Lausanne). 2022 Jun 30;13:849794. doi: 10.3389/fendo.2022.849794. eCollection 2022.
To investigate the adjuvant efficacy of metformin treatment to achieve pathological complete response (CR) in patients with endometrial complex hyperplasia (CH) and complex atypical hyperplasia (CAH), and secondarily, to evaluate their pregnancy outcomes after following assisted reproductive technology (ART).
This prospective cohort study analyzed 219 patients diagnosed with infertility and CH/CAH from January 2016 to December 2020. Among these patients, 138 were assigned to the control group (progesterone alone) and 81 were assigned to the study group (progesterone+metformin). After 8/12 weeks of therapy, the treatment responses were assessed by histological examination of curettage specimens obtained by hysteroscopy. Once the pathological results indicated CR, the patients were able to receive ART. The ART treatment and follow-up data of these patients were collected and analyzed.
116 patients in the control group achieved CR, compared with 76 patients in the study group. The CR rate in the control group was significantly lower than that in the study group (P=0.034). We then divided the patients into subgroups to compare the treatment responses. In the subgroup analyses, patients with body mass index (BMI) ≥25 kg/m and patients with polycystic ovarian syndrome (PCOS) had higher CR rates in the metformin group compared with the control group (P=0.015, P=0.028 respectively). Subsequently, 68 patients in the control group and 47 patients in the study group received an ART cycle. We examined the pregnancy indications and found no significant differences in the clinical pregnancy rate and live birth rate between the two groups (P>0.05).
Regression of CH/CAH may be improved by progesterone+metformin compared with progesterone alone. The effect was particularly pronounced in patients with BMI ≥25 kg/m and patients with PCOS. Metformin had no obvious effect on subsequent ART outcomes. The trial is registered on the publicly accessible website.
http://www.chictr.org.cn/showproj.aspx?proj=15372, identifier ChiCTR-ONR-16009078.
研究二甲双胍治疗子宫内膜复杂增生（CH）和复杂非典型增生（CAH）患者达到病理完全缓解（CR）的辅助疗效，并评估其随后接受辅助生殖技术（ART）后的妊娠结局。
本前瞻性队列研究分析了 2016 年 1 月至 2020 年 12 月期间因不孕和 CH/CAH 就诊的 219 例患者。其中 138 例患者被分配至对照组（单用孕激素），81 例患者被分配至研究组（孕激素+二甲双胍）。治疗 8/12 周后，通过宫腔镜下刮宫标本的组织学检查评估治疗反应。一旦病理结果提示 CR，患者即可接受 ART。收集并分析这些患者的 ART 治疗和随访数据。
对照组有 116 例患者达到 CR，而研究组有 76 例患者达到 CR。对照组的 CR 率明显低于研究组（P=0.034）。随后我们将患者分为亚组进行治疗反应比较。在亚组分析中，BMI≥25 kg/m2的患者和多囊卵巢综合征（PCOS）患者在二甲双胍组的 CR 率高于对照组（P=0.015，P=0.028）。随后，对照组有 68 例患者和研究组有 47 例患者接受了一个 ART 周期。我们检查了妊娠指征，发现两组的临床妊娠率和活产率无显著差异（P＞0.05）。
与单用孕激素相比，孕激素+二甲双胍可能改善 CH/CAH 的消退。在 BMI≥25 kg/m2的患者和 PCOS 患者中效果更为明显。二甲双胍对随后的 ART 结局没有明显影响。该试验在公开可访问的网站上注册。
http://www.chictr.org.cn/showproj.aspx?proj=15372，标识符 ChiCTR-ONR-16009078。
