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临床试验/NCT04744753
NCT04744753已完成4 期

Assisted Oocyte Activation (AOA) in Recurrent Fertilization Failure

MOHAMED BEHERY1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
fertilization rate

研究概览

简要总结

Background: Despite the high success rate of ICSI, total fertilization failure still occurs in 1-3% of all ICSI cycles and can recur in subsequent cycles, even when a sufficient number of oocytes and motile spermatozoa are available. Several reports show that the majority of couples suffering from ICSI failure benefit from the application of ICSI combined with assisted oocyte activation. A variety of artificial activating methods is used in human assisted reproduction treatment, including physical, mechanical or chemical stimuli, which provoke one or more calcium rises in the oocyte cytoplasm. Study Design: Randomized controlled trial. Setting: A university fertility center. Methods: 150 infertile patients who underwent ICSI and all had history of recurrent fertilization failure. The patients were randomly allocated into 2 equal groups. Group1=75 patients who underwent ICSI without oocyte activation. Group2 patients =75 and underwent ICSI Patient underwent ICSI with oocyte activation. Reproductive outcomes were compared between both groups. Results: there were significant differences between groups regarding number of oocytes retrieved, number of mature oocyte, fertilization rate and pregnancy rate. Conclusion: Assisted oocyte activation with calcium ionophore results in significant improvement in the fertilization, cleavage and pregnancy rates after ICSI.

详细描述

This study is a randomized controlled trial included 150 ICSI patients with history of recurrent fertilization failure. Patients had undergone ICSI trials in ART unit, Al-Azhar University, Cairo, Egypt, from July 2017 to November 2018. The study was approved by the university medical ethical committee (under registry number 202010454) and all couples had signed a written consent before initiation of the study and the treatment cycles. AOA candidate couples were counseled regarding the procedure. The patients were selected according to the following criteria:

Inclusion Criteria: -

  1. Age between 20 and 40 years old.
  2. Cases with history of total fertilization failure in previous ICSI cycles
  3. Oocytes with normal morphology.
  4. Male factor infertility. Exclusion Criteria: - Abnormal oocyte morphology degenerated or immature oocytes.

Two groups were randomly designated:

The first Group: The oocytes were treated by calcium ionophore. This group involved 75 ICSI 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
None

入排标准

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

入选标准

  • (1) Age between 20 and 40 years old. (2) Cases with history of total fertilization failure in previous ICSI cycles (3) Oocytes with normal morphology.

排除标准

  • (1) Abnormal oocyte morphology degenerated or immature oocytes. (2) Husbands with spermatogenic arrest or Sertoli/Leydig cells only.

研究组 & 干预措施

study group

Active Comparator

. This group involved 75 patients with history of fertilization failure in which oocytes were activated by calcium ionophores

干预措施: Calcium Ionophore A23187 (Drug)

结局指标

主要结局

fertilization rate

时间窗: one and half year for all patients

the number of reproduced embryos divided by the number of fertilized oocytes

次要结局

  • Pregnancy rate(one and half year for all patients)

研究者

发起方
MOHAMED BEHERY
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

MOHAMED BEHERY

Behery MA

Al-Azhar University

研究点 (1)

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