Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)

May 5, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital

Chaetoglobosin A Supplementation to ICSI Handling Medium

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Banon Assiut
      • Qena, Egypt, 123456
        • Qena Fertility Center
      • Sohag, Egypt, 12345
        • IbnSina IVF Center, IbnSina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All ICSI participants agreed

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: handling Medium as it is.
Experimental: Handling Medium Supplemented with Chaetoglobosin A
Other: Medium Supplemented with Chaetoglobosin A
A medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte Survival after ICSI
Time Frame: two days
Survived oocytes per MII injected
two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 6 days of culture
6 days of culture
Ongoing pregnancy rate
Time Frame: 12 weeks
12 weeks
Rate of top-quality embryo
Time Frame: 6 days of culture
Rate of top-quality embryo per fertilized oocytes
6 days of culture
blastocyst formation and quality
Time Frame: 6 days of culture
Number of formed blastocyst and high-quality blastocyst per fertilized oocytes
6 days of culture
blastocyst utilization rate
Time Frame: 6 days of culture
Number of transferred and vitrified embryos per fertilized oocytes
6 days of culture
clinical pregnancy rate
Time Frame: 7 weeks
Number of pregnant women per recruited cycles
7 weeks
Implantation rate
Time Frame: 7 weeks
sacs with a heartbeat per embryo transferred
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibn Sina Hospital

Collaborators

Banoon IVF Center
Qena Fertility Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2018

Primary Completion (Actual)

May 2, 2019

Study Completion (Actual)

May 3, 2019

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 5, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IbnSinaIVF-ICSI-CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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