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临床试验/NCT05055245
NCT05055245Unknown不适用

Stress in Couples Undergoing Assisted Reproduction Technology With Different Cycles and Its Impact on Pregnancy Outcomes

Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年10月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
clinical pregnancy rate

研究概览

简要总结

With the development of assisted reproductive technology (ART), more and more infertile women are obtaining their offspring through assisted reproductive technology. However, a growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during ART treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of ART. The purpose of this study is to investigate the stress faced by participants undergoing ART with different cycles and to further investigate its impact on pregnancy outcomes.

详细描述

With the rapid social and economic development in recent years, the incidence of infertility has increased significantly due to environmental pollution, poor lifestyle habits and increasing stress in various areas. According to global statistics, one in six married couples suffers from infertility. With the development of assisted reproductive technology (ART), more and more infertile women are obtaining their offspring. In clinical practice, however, a significant proportion of patients undergoing ART have low embryo implantation and pregnancy rates and experience recurrent implantation failure (RIF). A growing number of national and international studies have shown that infertility patients are prone to negative emotions such as anxiety and depression during ART treatment, which not only affects their physical and mental health, but also affects the embryo implantation rate and pregnancy rate of ART. This effect is more pronounced in patients with multiple failed transfers. In this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with different cycles to provide a reliable basis for future psychological interventions and health education for this group of patients and improve the quality of life of infertility patients.

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
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Female partners' >18< 40 years
  • Patients undergoing assisted reproductive technology

排除标准

  • Female partners with polycystic ovary
  • Female partners with insufficiency or premature ovarian failure
  • Female partners with endometriosis
  • Female partners with abnormal profile of thyroid hormones
  • Chromosomal abnormalities of either spouse
  • Mental disorder of either spouse

结局指标

主要结局

clinical pregnancy rate

时间窗: 6 months

presence of at least one gestational sac on ultrasound of 6 weeks

Implantation rate

时间窗: 6 months

Implantation rate is defined as number of sacs per embryo transferred.

次要结局

  • Metaphase II (MII) oocytes(6 months)
  • Total gonadotropin use(6 months)
  • Ovarian hyperstimulation syndrome (OHSS) rates(6 months)
  • fertilization rate(6 months)
  • cleavage rate(6 months)
  • Number of oocytes retrieved(6 months)

研究者

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

Yimin Zhu

Chief Physician

Women's Hospital School Of Medicine Zhejiang University

研究点 (1)

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