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临床试验/NCT04924309
NCT04924309Unknown不适用

Stress in Couples Undergoing Assisted Reproduction Technology With Donor Insemination and Its Impact on Reproductive 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7月5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
Implantation rate

研究概览

简要总结

Donor sperm provides a viable option for patients with significant male factor infertility. However, since the source of sperm is not from the male partner, the psychological burden of these couples is more pronounced and complex than other patients.The purpose of this study is to investigate the stress faced by participants undergoing assisted reproduction with donor sperm and to further investigate its impact on pregnancy outcomes.

详细描述

The number of infertility patients has increased significantly in recent years, and infertility caused by the male partner accounts for about 30%-50% of infertility factors. Donor sperm provides a viable option for patients with significant male factor infertility. However, since the source of sperm is not from the male partner, the psychological burden of these couples is more pronounced and complex than other patients. Many factors such as social, marital, and family problems may contribute to their depressed emotional state. And the impact of these negative emotions on pregnancy outcomes cannot be ignored. In this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with donor sperm 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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female partners' >18< 40 years
  • Male partners' >18< 40 years
  • Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor

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

Implantation rate

时间窗: 8 months

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

clinical pregnancy rate

时间窗: 8 months

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

次要结局

  • fertilization rate(8 months)
  • cleavage rate(8 months)
  • Total gonadotropin use(8 months)
  • Metaphase II (MII) oocytes(8 months)
  • Ovarian hyperstimulation syndrome (OHSS) rates(8 months)
  • Number of oocytes retrieved(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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