Viewing Study NCT04519918



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Last Modification Date: 2024-10-26 @ 1:43 PM
Study NCT ID: NCT04519918
Status: UNKNOWN
Last Update Posted: 2020-09-01
First Post: 2020-07-30

Brief Title: Clinical Application of Artificial Oocyte Activation Technique AOA in ART
Sponsor: Tang-Du Hospital
Organization: Tang-Du Hospital

Study Overview

Official Title: Clinical Application of Artificial Oocyte Activation Technique AOA in Assisted Reproduction Technology
Status: UNKNOWN
Status Verified Date: 2020-08
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Oocyte activation is an imperative stage in the initiation of embryo development during the fertilization Indeed the entrance of sperm into the oocyte causes sequences of calcium oscillations in its cytoplasm regulating a series of molecular events called oocyte activation The intracytoplasmic sperm injection ICSI has allowed fertilization in couples with severe male factor infertility But there was still fertilization failure or low fertilization occurs in ICSI cycles It has reported that insufficient of oocyte activation is the important cause of fertilization failure Artificial oocyte activation AOA represents an effective technique can restore the calcium oscillations to improve the fertilization Here the investigators explore the effective of different AOA methods including oocyte was injected CaCl2 or mechanical stimulated then treated with calcium ionophore
Detailed Description: The ICSI procedure improves fertilization rates in cases of male factor infertility However fertilization failure still occurs in 1-5 in ICSI cycles The main cause of failed fertilization is failure to complete oocyte activation Oocyte activation involves a multitude of molecular changes The investigators use a variety of mechanical electrical and chemical methods to trigger the calcium oscillations necessary to activate oocytes During mechanical activation of oocytes oolemmas are pierced using a microneedle to trigger a calcium influx Another method for mechanical oocyte activation is the direct microinjection of calcium into the oocyte to increase intracellular calcium It has been described with the use of calcium ionophore A23187 which can mimic the natural pattern of calcium rise Mechanical and chemical activation are the most commonly used methods for artificial oocyte activation can mimic calcium oscillations resulting in successful fertilization AOA a highly specialized fertilization technique that can be added to conventional ICSI to overcome fertilization failure in patients that had failed fertilization or poor quality embryos history

When the number of retrieved oocytes was 10 sibling oocytes were divided into 3 groups to perform the standard ICSI procedure control group chemical AOA A1 experiment group or mechanical AOA A2 experiment group When the number of retrieved oocytes was 6-10 sibling oocytes were randomized 11 to perform the chemical AOA A1 experiment group or mechanical AOA A2 experiment group The number of retrieved oocytes was 1-5 all oocytes were perform the chemical AOA Control group a single spermatozoon was injected into the ooplasm standard ICSI procedure A1 experiment group were treated by injecting CaCl2 concurrently with ICSI followed by sequential exposure of calcium ionophore A23187 activation solution for two times of post-ICSI AOA A2 experiment group mechanical stimulation was done before standard ICSI procedure then the oocytes were transferred into the calcium ionophore A23187 activation solution for two times of post-ICSI AOA The investigators want to establish the effective and safe of different AOA methods to improve the fertilization outcome and embryo quality and finally obtain healthy offspring

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None