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临床试验/NCT01882166
NCT01882166终止不适用

Time-lapse Monitoring of Early Embryo Development After Ovarian Stimulation During Infertility Treatment

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年10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
状态
终止
发起方
入组人数
20
试验地点
1
主要终点
Embryo quality

研究概览

简要总结

The number of children conceived by assisted reproductive technology is increasing in Nordic countries as well as worldwide. An important factor of success in treatment of infertility is a short "time to pregnancy" with impact on both economical aspects for the society and medical and psychological aspects for the couple. During treatment, success relies on 1) optimal stimulation of growth and maturation of multiple follicles by administration of exogenous follicle stimulating hormone (FSH), and 2) selection of the fertilized egg / embryo with the highest potential of implantation to be transferred to the mother. In the present project stimulation of egg production by human urine derived FSH (Fostimon®) and recombinant FSH (Puregon®) will be compared. To this end early embryo development and kinetics after fertilization will be evaluated. The system to be used is time-lapse recording of embryo morphology during the first days of embryo development by means of an embryoscope. Aim of this study is to investigate if Puregon and urinary Fostimon have different effect on embryo quality. The hypothesis of the study is that stimulation of egg production by these two types of follicle stimulating hormone does not have the same effect on early embryo quality.

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
None

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • First or second intracytoplasmic sperm injection (ICSI) treatment
  • BMI 18-32 kg/m²
  • No previous ovarian hyperstimulation syndrome (OHSS)
  • Regular menstrual cycle (cycle length 28 ± 3 days
  • Less than 20 antral follicles evaluated by vaginal ultrasound
  • S- Anti-Müller Hormone (AMH) 10 - 40 pmol/L
  • has given informed consent

排除标准

  • 未提供

研究组 & 干预措施

fostimon

Experimental

subcutaneous 150 IE Fostimon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later.

干预措施: fostimon (Drug)

puregon

Experimental

subcutaneous 150 IE Puregon®. When leading follicles are > 17 mm ovulation will be induced by Ovitrelle® 500μg sc(hCG-injection). Ovum pick up (OPU) will be performed 32-36 hours later.

干预措施: puregon (Drug)

结局指标

主要结局

Embryo quality

时间窗: 2 days

time-lapse recordings for all embryos will be evaluated by use of the EmbryoViewer (software developed for the EmbryoScope)

次要结局

未报告次要终点

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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