Effect of transvaginal Lactobacillus supplementation on reversing lower genital tract dysbiosis and improving perinatal outcomes in PCOS patients after IVF-FET: a study protocol for a multicenter randomized controlled trial

DiscussionThis is the first large and multicenter randomized controlled trial aimed at assessing the efficacy of transvaginalLactobacillus 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.Ethics and disseminationEthical 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.Trial registrationChiCTR ChiCTR2000036460. Registered on 13 September 2020,https://www.chictr.org.cn/showproj.html?proj=59549.
Source: Trials - Category: Research Source Type: clinical trials