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临床试验/NCT05545631
NCT05545631招募中不适用

Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Concentration of serum human chorionic gonadotropin ≥10 mIU/mL

研究概览

简要总结

This study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;
  • Female age: 20-45 years old;
  • Single frozen-thawed blastocyst Transferred
  • Endometrial thickness ≥7mm on the day of luteal transformation
  • Written informed consent.

排除标准

  • Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease;
  • Untreated hyperprolactinemia, thyroid disease, adrenal disease
  • Antibiotic use within the past 7 days;
  • Current or recent (within 3 months) drug abuse, including alcohol and tobacco;
  • Refused or unable to comply with protocol requirements;
  • Participation in any experimental drug study within 60 days prior to screening.

结局指标

主要结局

Concentration of serum human chorionic gonadotropin ≥10 mIU/mL

时间窗: 09.01.2022 to 09.01.2024

Conception

次要结局

  • Clinical pregnancy(09.01.2022 to 09.01.2024)

研究者

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

Xiuxia Wang

Principal Investigator

Shengjing Hospital

研究点 (1)

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