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临床试验/NCT04697823
NCT04697823招募中不适用

Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial

KU Leuven2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
KU Leuven
入组人数
400
试验地点
2
主要终点
number of transfers needed to reach ongoing pregnancy

研究概览

简要总结

Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

double blind

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with own oocytes/embryos;
  • Patients with female age at 1st OR in the study <40 year;
  • Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval
  • Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals
  • Patients with female age at 1st OR in the study <40 year;
  • Patients with BMI ≤32;
  • Patients with written informed consent;

排除标准

  • 未提供

结局指标

主要结局

number of transfers needed to reach ongoing pregnancy

时间窗: ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy

The primary outcome parameter is the number of transfers needed to reach ongoing pregnancy (ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy), as a time-to-event outcome variable. Patients that do not reach pregnancy, are censored at their last transfer.

次要结局

  • number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy(until Live birth: 9 months after ET)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sophie Debrock

clinical embryologist

KU Leuven

研究点 (2)

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