A Prospective Randomized Controlled Trial: Short-Time In Vitro Maturation For Improvement of Oocytes Quality And Reproductive Outcomes

Abstract Background: Current standard stimulation protocols use gonadotropins (recombinant or hMG) combined with LHRH agonists to prevent premature ovulation to obtain an average of 10-15 mature oocytes per retrieval. However, it usually has some immature oocytes retrieved with mature oocytes even after triggering LH surge. Compared to fertilization medium, IVM medium may be more effective in stimulating the maturation of oocyte nucleoplasm. This study aimed to explore the effect of short-term culture in our novel IVM medium on oocyte maturity and subsequent embryonic development in current standard stimulation protocols.Methods/Design: This study is a multicenter, prospective, randomized controlled clinical trial (1:1 treatment ratio of short term IVM group or control group). we will need to enroll 1860 participants in each group; that is, a total of 3720 participants. The The retrieved cumulus-oocyte complexes（COCs） of the short-term IVM group were exposed to IVM medium immediately after retrieval and subsequently incubated for 4 hours,and COCs in control group were cultured in G-IVF PLUS in 4-wells culture dish after retrieval. The primary study endpoint is number of available embryos: defined as number of embryos d≥4cells and ≤30% fragmentation (except embryos developed from ≥3 PN zygotes) on day 3 of observation. All tests were two-tailed, and differences with p value<0.001 for interim analysis or p-value <0.05 for final analysis are considered statistically significant.Discussion:This study aimed to explore the effect of short-term culture in our novel IVM medium on oocyte maturity and subsequent embryonic development.Trial registration: chictr.org.cn Identifier:ChiCTR2000038043