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临床试验/NCT03904745
NCT03904745Unknown不适用

Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年12月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
250
试验地点
2
主要终点
Pregnancy rates

研究概览

简要总结

Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.

详细描述

Inhibition of uterine contractions in order to increase implantation rates have been studied on several agents in the last two decades. Beta-adrenergic agonists and non-steroidal anti-inflammatory drugs have been shown to have no benefit on implantation rates. Vasopressin V1a and oxytocin receptor antagonist atosiban was first studied on premature labor patients and found to be effective.

Endometrium-originated oxytocin can possibly stimulate myometrium and have a negative impact on embryo implantation. Inhibition of oxytocin receptors has been shown to reduce uterine contraction frequency in non-pregnant women. Atosiban has been studied on assisted reproductive technologies in the last decade and has been shown to be effective on increasing implantation and clinical pregnancy rates. However, previous studies have used a 37,5 mg total dose of atosiban which was used both before and during embryo transfer. We aim to use a single and low dose of 6,75mg atosiban only before embryo transfer, which is simpler and cheaper and the medication given to patient is significantly lower. If we can demostrate the positive effect of our protocol, it can be suggested to be used routinely in all in vitro fertilization cycles. Additionally, our study is an original study in terms of being the first randomized clinical trial studying the effect of atosiban on frozen-thawed embryo transfer cycles.

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

  • Infertile women applied to assisted reproduction clinic
  • Follicle stimulating hormone < 12
  • Body mass index < 25
  • Patients whom antagonist protocol will be used
  • Patients whom at least 2 good-quality embryos obtained
  • Patients who are volunteer

排除标准

  • Severe male factor (Sperm concentration <5 M/ml, progressive sperm motility <%10)
  • Uterine anomaly
  • Hydrosalphynx
  • Difficult embryo transfer
  • Patients who previously had a diagnosis of endometriosis and / or adenomyosis
  • Endocrine problems (hypothyroidism, hyperthyroidism, hyperprolactinemia, premature ovarian insufficiency)
  • Having more than 3 in vitro fertilization failure
  • Refusing to participate

研究组 & 干预措施

Atosiban used before embryo transfer

Experimental

the patients in this group will be administered 6,75mg atosiban intravenously.

干预措施: Atosiban (Drug)

结局指标

主要结局

Pregnancy rates

时间窗: 1 year

Pregnancy rates of the participants

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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