Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China.
The International Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Trials. 2023 Dec 21;24(1):821. doi: 10.1186/s13063-023-07825-9.
Significant lower genital tract (LGT) dysbiosis and an associated lower rate of clinical pregnancy after in vitro fertilization-frozen embryo transfer (IVF-FET) among polycystic ovary syndrome (PCOS) patients have been previously reported by our group. We aimed to assess whether transvaginal Lactobacillus supplementation can reverse LGT dysbiosis and further improve perinatal outcomes in PCOS patients after IVF-FET.
METHODS/DESIGN: This is a protocol for a multicenter, open-label, randomized controlled trial in China. Women diagnosed with PCOS who are undergoing IVF-FET treatment will be recruited. Allocation to the intervention/control arms at a ratio of 1:1 will be executed by an electronic randomization system. Participants in the intervention arm will receive the live Lactobacillus capsule vaginally for 10 consecutive days before embryo transfer, while those in the control arm will receive standard individualized care. The primary outcomes will be the clinical pregnancy rate, implantation rate, and live birth rate. 16S rRNA sequencing and liquid chromatography-mass spectrometry will be conducted to evaluate the LGT microbiome and systemic metabonomics before and after the intervention. A sample of 260 participants will provide 95% power to detect a 20% increase in the rate of clinical pregnancy (α = 0.025, one-tailed test, 15% dropout rate). A total of 300 participants will be recruited.
This is the first large and multicenter randomized controlled trial aimed at assessing the efficacy of transvaginal Lactobacillus supplementation on restoring the LGT microbiome and improving perinatal outcomes in PCOS patients after IVF-FET. This pragmatic trial is promising for increasing the rates of clinical pregnancy and live birth in PCOS patients after IVF-FET.
Ethical review approval was obtained from the Medical Research Ethics Committees of the International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University (15 October 2020, GKLW 2020-29). To maximize dissemination, these findings will be reported in open access publications in journals with high impact, and oral and poster conference presentations will be performed.
ChiCTR ChiCTR2000036460. Registered on 13 September 2020, https://www.chictr.org.cn/showproj.html?proj=59549 .
本研究团队先前报道多囊卵巢综合征（PCOS）患者体外受精-冻融胚胎移植（IVF-FET）后下生殖道（LGT）明显失调，临床妊娠率较低。我们旨在评估阴道乳酸杆菌补充是否可以逆转 LGT 失调，并进一步改善 PCOS 患者 IVF-FET 后的围产期结局。
方法/设计：这是一项在中国进行的多中心、开放标签、随机对照试验的方案。将招募接受 IVF-FET 治疗的诊断为 PCOS 的女性。通过电子随机系统以 1:1 的比例将参与者分配到干预/对照组。干预组的参与者将在胚胎移植前连续 10 天阴道内使用活菌乳酸杆菌胶囊，而对照组的参与者将接受标准的个体化护理。主要结局为临床妊娠率、着床率和活产率。16S rRNA 测序和液相色谱-质谱联用将在干预前后评估 LGT 微生物组和系统代谢组学。260 名参与者的样本将提供 95%的功效来检测临床妊娠率增加 20%（α=0.025，单侧检验，15%的脱落率）。共招募 300 名参与者。
这是第一项旨在评估阴道乳酸杆菌补充对恢复 PCOS 患者 IVF-FET 后 LGT 微生物组和改善围产期结局的疗效的大型多中心随机对照试验。这项实用试验有望提高 PCOS 患者 IVF-FET 后的临床妊娠率和活产率。
上海交通大学国际和平妇幼保健院医学研究伦理委员会于 2020 年 10 月 15 日（GKLW 2020-29）获得伦理审查批准。为了最大限度地传播这些发现，将在具有高影响力的开放获取期刊上以公开访问的形式发表这些研究结果，并进行口头和海报会议报告。
ChiCTR ChiCTR2000036460。于 2020 年 9 月 13 日注册，https://www.chictr.org.cn/showproj.html?proj=59549。
