Stress in Couples Undergoing Assisted Reproduction Technology With Different Cycles and Its Impact on Pregnancy Outcomes
2021年9月14日 更新者:Yimin Zhu、Women's Hospital School Of Medicine Zhejiang University
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Yimin Zhu, Dr.
- 电话号码:057189992071
- 邮箱:zhuyim@zju.edu.cn
学习地点
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- Women's Hospital, School of Medicine, Zhejiang University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 40年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients undergoing assisted reproductive technology
描述
Inclusion Criteria:
- Female partners' >18< 40 years
- Patients undergoing assisted reproductive technology
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients undergoing assisted reproductive technology
Patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
|
Patients are grouped according to the number of IVF/ICSI cycles.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Implantation rate
大体时间:6 months
|
Implantation rate is defined as number of sacs per embryo transferred.
|
6 months
|
|
clinical pregnancy rate
大体时间:6 months
|
presence of at least one gestational sac on ultrasound of 6 weeks
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
回收的卵母细胞数量
大体时间:6个月
|
6个月
|
|
|
fertilization rate
大体时间:6 months
|
No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs)
|
6 months
|
|
cleavage rate
大体时间:6 months
|
No. of cleaved embryo divided by No. of fertilized oocyte
|
6 months
|
|
Total gonadotropin use
大体时间:6 months
|
Total gonadotropin use of each participant
|
6 months
|
|
Ovarian hyperstimulation syndrome (OHSS) rates
大体时间:6 months
|
OHSS rates in both study groups
|
6 months
|
|
Metaphase II (MII) oocytes
大体时间:6 months
|
the number of mature oocytes
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Yimin Zhu, Dr.、Women's Hospital School Of Medicine Zhejiang University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年10月9日
初级完成 (预期的)
2022年3月9日
研究完成 (预期的)
2022年4月9日
研究注册日期
首次提交
2021年9月14日
首先提交符合 QC 标准的
2021年9月14日
首次发布 (实际的)
2021年9月24日
研究记录更新
最后更新发布 (实际的)
2021年9月24日
上次提交的符合 QC 标准的更新
2021年9月14日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.