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临床试验/NCT01549171
NCT01549171Unknown不适用

Pilot Study to Examine Iloprost Can Enhance Human Assisted Reproductive Technology Pregnancy Outcomes.

Fertility Specialists of Houston1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Presence of embryo sac in uterus under ultrasound

研究概览

简要总结

Human fallopian tube secretes high concentration of prostacyclin. Fallopian tube is the site for early embryo development. The effect of prostacyclin on human early embryo development is waiting to be clarified. The study hypothesis is prostacyclin can enhance early embryo development.

详细描述

Huang et al, found that human fallopian tube expresses prostacyclin synthetase and cyclooxygenase. These enzyme systems synthesize abundant prostacyclin (PGI2). In the fallopian tube PGI2 causes smooth muscle relaxation, possibly facilitating tubal transport of gametes and embryos. Huang et al reported that addition of the PGI2 analogue Iloprost to embryo culture media significantly enhanced mouse embryo development to the blastocyst and complete hatched stages. The implantation and live birth rates of Iloprost cultured embryos were significantly better than non-Iloprost embryos in the mouse model. The mean weights of fetal mice were not significant different from control group. There was no teratogenic effect observed.

In a previously presented study, the investigators cultured donated frozen human zygotes in culture media with and without the addition of Iloprost. The Iloprost treated embryos showed significantly better growth rate and morphology, as determined by the size, and grading of the trophectoderm and inner cell mass.

Iloprost is FDA approved for the treatment of pulmonary hypertension. It has a significantly longer half-life than native PGI2. Iloprost is a class C pregnancy drug and has not been associated with teratogenic effects. This study intends to expand the usage of Iloprost to culture embryos.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • age < 40
  • no pre-implantation genetic diagnosis procedure

研究组 & 干预措施

Iloprost

This is the study group with 1 uM Iloprost.

干预措施: Iloprost (Drug)

Control

This is the control group with vehicle (normal saline) only.

干预措施: normal saline (Other)

结局指标

主要结局

Presence of embryo sac in uterus under ultrasound

时间窗: 5 weeks after embryo transfer

The competency of embryo is determined by its ability to implant into endometirum.

次要结局

  • The delivery outcome is the secondary outcome measured.(10 months after embryo transfer)

研究者

发起方
Fertility Specialists of Houston
申办方类型
Other
责任方
Sponsor

研究点 (1)

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