评估在IVF随机对照试验中设定的不孕症核心结果的吸收率
Wenqiang Li1,2, Nanxi Jia1,3, Hongbin Chi4
1Research Center of Clinical Epidemiology, Peking University Third Hospital, Haidian District, Beijing, China.
Human reproduction (Oxford, England)
|December 14, 2024
概括
不孕症核心结局集在临床试验中显示了日益增长但低于最佳的采用率. 预期注册和更大的样本大小等因素提高了结果的一致性,突出了需要更好的推广和协作.
科学领域:
- 生殖医学和临床试验
- 基于证据的医学标准化标准化
背景情况:
- 不孕症核心结果集是为了规范报告和防止偏见而建立的.
- 关于其实际采用和对临床试验结果的影响的研究有限.
- 评估采用对于促进透明度和有效的资源分配至关重要.
研究的目的:
- 评估在随机对照试验 (RCT) 中设定的不孕症核心结果的吸收率.
- 确定影响不孕不育RCT结果选择和报告的因素.
- 确定未来改善核心成果集实施的领域.
主要方法:
- 一项横截面研究分析了来自18个注册机构的1673个RCT关于不孕不育的注册 (2004-2024年).
- 在RCT中报告的结果与不孕症核心结果组建议进行了比较.
- 潜在的影响因素包括研究期,目标样本大小和潜在的注册.
主要成果:
- 怀孕结果 (例如,子宫内妊娠) 的摄入量高于新生儿结果.
- 宫内怀孕,活产和流产显示出相对较高的收养率.
- 预期注册和更大的目标样本大小显著改善了结果与核心集合的一致性.
结论:
- 核心成果集的采用正在增加,但仍然不足以达到最佳水平,结果领域之间存在显著的差异.
- 除了核心出版集之外的因素影响了采用趋势.
- 加强推广,提高研究人员的认识和利益相关方的合作对于改善吸收是必不可少的.
相关概念视频
In Vitro Fertilization
214
In vitro fertilization (IVF) is a form of assisted reproductive technology where an egg is fertilized with sperm in a controlled laboratory environment before transferring the resulting embryo into the uterus. This process is designed to help individuals and couples experiencing difficulties conceiving.
The IVF process begins with ovarian stimulation, during which reproductive endocrinologists prescribe hormonal medications to stimulate the ovaries to produce multiple eggs instead of the single...
The IVF process begins with ovarian stimulation, during which reproductive endocrinologists prescribe hormonal medications to stimulate the ovaries to produce multiple eggs instead of the single...
214
Infertility in Females
275
Female infertility is defined as the inability to conceive after a year of regular, unprotected intercourse and affects about 10–15% of couples worldwide. The primary cause of female infertility is ovulatory disorders, which hinder the release of eggs. These disorders can be classified as hypothalamic amenorrhea, polycystic ovarian syndrome (PCOS), premature ovarian failure, and hyperprolactinemic anovulation disorders.
Endometriosis, a condition characterized by abnormal growth of...
Endometriosis, a condition characterized by abnormal growth of...
275
Infertility in Males
242
Male infertility affects millions of couples worldwide, arising from various factors that impact different stages of the reproductive process. An endocrine imbalance resulting from conditions like hypogonadism, Klinefelter syndrome, or pituitary disorders can disrupt hormone levels and reduce sperm production. Testicular defects, such as tumors, cryptorchidism, atrophic testes, abnormal sperm morphology, and low sperm count or motility, may arise due to genetic factors, structural...
242
Clinical Trials: Overview
2.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.7K
Clinical Trials
6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.6K
Study Design in Statistics
7.8K
A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
7.8K


