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临床试验/NCT03679000
NCT03679000Unknown不适用

Periconceptional Phthalates Exposure and Its Epigenetic Effect on Fertility, Embryo Development, and Neonatal Outcomes: a Prospective Study

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 2,122 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,122
试验地点
1
主要终点
Phthalates exposure levels

研究概览

简要总结

The study is a prospective cohort study, which is aiming to explore periconceptional phthalates exposure and its potential epigenetic effect on fertility, embryo development, and neonatal outcomes.

详细描述

The study is a prospective cohort study, and its subjects are childbearing couples who are seeking assisted reproductive technologies for having a baby in the reproductive center in Tongji Hospital.

  1. All enrolled couples will be needed to sign an informed consent and complete a questionnaire for collecting information about demographics, life-style, and medical and reproductive histories.
  2. Biological samples will be collected from the participants to measure phthalates metabolites in order to evaluate the exposure of single person or the couple in different time phase.The samples include urine, blood that will be left after the hormones measurement for both spouses. The follicular fluid will be obtained from females on the day of oocyte retrieval. The left sperm samples after sperm analysis will be obtained from men. In the reproductive center of Tongji Hospital, hormone measurement for women and sperm analysis for men are required for the In vitro fertilization and embryo transfer in order to evaluate the fertility of couples.And the blastocyst culture medium will be obtained from couples after blastocyst transfer. All samples will be stored at -80℃ until further analysis.
  3. Measurements of phthalates metabolites in the biological samples.
  4. Collecting data from electronic medical records and follow-up.The basic information, clinical data and reproductive outcomes of the subjects will be collected by reviewing the electronic medical charts, including the height, weight, basic hormone levels, stimulation protocol and time, insemination protocol, fertilization rate, cleavage rate, excellent embryo rate, blastocyst formation rate, clinical pregnancy rate, as well as live birth rate,the newborns' height, weight, and gestational age, etc.
  5. Analyze the miRNA expression profiles of blastocyst culture medium.
  6. Statistical analysis. The investigators will analyze the association between the couples' phthalates exposure levels and the reproductive outcomes, and explore the association among periconceptional phthalates exposure, epigenetic changes and reproductive outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Phthalates exposure levels

时间窗: 12/2021

Concentrations of phthalates in ng/ml

次要结局

  • Exposure characteristics of phthalates(12/2021)
  • Reproductive outcomes(12/2021)
  • The expression profiles of miRNA(12/2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liyufeng

Principal Investigator

Tongji Hospital

研究点 (1)

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