跳至主要内容
临床试验/NCT03799107
NCT03799107已完成不适用

The Developmental Epidemiological Study of Children Born Through Reproductive Technology

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 2,020 人开始时间: 2017年7月14日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验