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临床试验/NCT03940495
NCT03940495已完成不适用

A Prospective Study to Evaluate Whether Serum Kisspeptin is a Marker Predictive of the First Trimester Miscarriage of Women Who Conceive in IVF

ShangHai Ji Ai Genetics & IVF Institute1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
182
试验地点
1
主要终点
Early miscarriage loss

研究概览

简要总结

This is a prospective observational study. Eligible women undergo ART treatment in our centre will be recruited for the study and each woman will only be included in the study once. Informed written consent will be obtained. Blood serum for hCG level is performed 14 days after the embryo transfer i.e. week 4. If the serum hCG level is >10IU/L, the women are considered pregnant and blood will be saved and checked for kisspeptin level, Another blood test is repeated 1 week later i.e. week 5. A transvaginal ultrasound and blood test will be performed 1 week later i.e. week 6 to confirm the fetal viability and the number of gestational sacs and locate the pregnancy.

Blood for hCG and kisspeptin levels are checked at weeks, 4, 5 and 6. Ultrasound will be performed at gestational 8 weeks and 11 weeks. They will be referred for antenatal care when the pregnancy is confirmed on-going at 11 weeks.

The purpose is to determine whether serum kisspeptin level in women who conceive in IVF is associated with an increased risk in first trimester miscarriage and compare with serum hCG level in the prediction of the first trimester miscarriage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women who have a positive pregnancy test following IVF or frozen-thawed transfer

排除标准

  • Women with renal failure are excluded due to assay interference with kisspeptin measurement

结局指标

主要结局

Early miscarriage loss

时间窗: 10 weeks

defined as intrauterine pregnancy loss at less than 10 weeks' gestation as identified by ultrasound, including identification of empty sac, miscarriage, yolk sac miscarriage and embryonic miscarriage

次要结局

  • Biochemical pregnancy(8 weeks)
  • Positive hCG level(4 weeks)

研究者

发起方
ShangHai Ji Ai Genetics & IVF Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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