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临床试验/NCT01674283
NCT01674283撤回4 期

Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization

Clinique Ovo1 个研究点 分布在 1 个国家开始时间: 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
4 期
状态
撤回
发起方
试验地点
1
主要终点
Uterine muscle relaxation

研究概览

简要总结

The success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. It is through parenteral injection of glucagon and its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the time of embryo transfer, the investigators intend to improve the pregnancy rates obtained after IVF.

详细描述

Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer, the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes before the embryo transfer. The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and we will proceed to embryo transfer.

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
Single (Participant)

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

  • Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM
  • Less than 40 years old
  • Women with stimulate in vitro fertilization cycle
  • Women able to give her consent

排除标准

  • Body mass index > 35 kg/m2
  • Women with diabetes
  • Women with hypertensive disorders
  • Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit
  • Cons-indication to taking Glucagon:
  • Hypersensitivity to product
  • Pheochromocytoma or history of pheochromocytoma
  • Insulinoma
  • Taking a beta-blocker (drug interactions)

研究组 & 干预措施

Glucagon

Experimental

The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of Glucagon.

The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer.

干预措施: Glucagon (Drug)

Sodium chloride 0.9%

Placebo Comparator

The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of the placebo.

The second recording is doing the same way 10 minutes after the placebo injection, just before the embryo transfer.

干预措施: placebo (Drug)

结局指标

主要结局

Uterine muscle relaxation

时间窗: 30 minutes

Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.

次要结局

  • Embryo implantation and pregnancy rate(7 weeks)

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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