The Developmental Epidemiological Study of Children Born Through Reproductive Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,020
- 试验地点
- 2
- 主要终点
- Metabolic testing of child - LDL cholesterol
研究概览
简要总结
DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.
详细描述
Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist.
In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 4 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective arm
- •Inclusion criteria:
- •- children conceived by parent(s) who sought evaluation/treatment for infertility
排除标准
- •- Children with chronic medical illnesses that prevent a study visit
- •Prospective arm
- •Inclusion criteria:
- •- seeking evaluation/treatment for infertility
- •Exclusion criteria:
研究组 & 干预措施
Prospective
People who have sought evaluation/treatment for infertility
Retrospective
Children born with assistance
结局指标
主要结局
Metabolic testing of child - LDL cholesterol
时间窗: 1 day at study visit
LDL cholesterol mg/dL
Metabolic testing of child - fasting insulin
时间窗: 1 day at study visit
Fasting insulin uIU/mL
Metabolic testing of child - Triglycerides
时间窗: 1 day at study visit
Triglycerides mg/dL
Metabolic testing of child - Alanine Aminotransferase
时间窗: 1 day at study visit
Alanine Aminotransferase (ALT) U/L
Metabolic testing of child - fasting glucose
时间窗: 1 day at study visit
Fasting glucose mg/dL
Metabolic testing of child - uric acid
时间窗: 1 day at study visit
uric acid mg/dL
Metabolic testing of child - total cholesterol
时间窗: 1 day at study visit
Cholesterol, Total mg/dL
Metabolic testing of child - HDL cholesterol
时间窗: 1 day at study visit
HDL cholesterol mg/dL
Metabolic testing of child - cholesterol ratio
时间窗: 1 day at study visit
CHOL/HDLC ratio
Metabolic testing of child - non-HDL cholesterol
时间窗: 1 day at study visit
Non-HDL cholesterol mg/dL
次要结局
未报告次要终点
