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临床试验/NCT05788822
NCT05788822Unknown不适用

A Single-center Randomized Controlled Trial on Mevalproic Acid Improving Oocyte Quality and Embryo Development in Elderly Infertile Patients

Nanjing University1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2022年10月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
148
试验地点
1
主要终点
Embryo haploid rate

研究概览

简要总结

The goal of this clinical trial is to test MVA on improving pregnancy outcome in elderly infertile patients undergoing invitro fertilization (IVF). The main question it aims to answer is whether MVA could improve embryo haploid rate. Participants requested IVF are asked to randomly culture equal numbers of oocyte and embryo with or without MVA. Therefore, sibling oocytes were randomly divided into test group and control group.

详细描述

After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study co compare different treatment methods on the embryo development. Sibling eggs were randomly divided into test group and control group. Specific method of randomization: all the eggs of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were cultured with MVA, while the control oocytes were cultured without MVA. Thus, half of the eggs from each elderly infertile patient were treated with MVA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
38 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 38 years ≤ age ≤ 42 years;
  • Number of IVF/ICSI cycles ≤ 2

排除标准

  • Egg donor cycle
  • Chromosome abnormality;
  • Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases;
  • Patients with repeated implantation failure

结局指标

主要结局

Embryo haploid rate

时间窗: one month after oocyte retrival

Preimplantation genetic testing (PGT) was used to test embryo haploid rate

次要结局

未报告次要终点

研究者

发起方
Nanjing University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-jun Ding

reseaerch fellow

Nanjing University

研究点 (1)

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