Artificial Oocyte Activation Comparing Tow Different Agents

February 15, 2018 updated by: Muhammad Fawzy, Ibn Sina Hospital
Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The IVF outcome had been varied widely with a good portion of total fertilization failure even after the most advanced procedure for this group of patient Intracytoplasmic Sperm Injection, many factors that had been tested for assisting the failed group of patient to be fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to compare the clinically proven factors for the efficacy and safety in a well randomized clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.

Study Type

Interventional

Enrollment (Actual)

450

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

  • Bahrain
      • Manama, Bahrain
        • Al Barka fertility center
  • Egypt
      • Assiut, Egypt
        • Banon Fertility Center
      • Sohag, Egypt
        • IbnSina IVF Center

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • previous fertilization failure
  • poor quality Oocytes
  • poor sperms

Exclusion Criteria:

  • normal patients

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ca Ionophore group
Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection
Other: Artificial Oocyte activation
Drug: Ca Ionophore
Experimental: Strontium Chloride group
Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection
Other: Artificial Oocyte activation
Drug: Strontium Chloride
No Intervention: Only Intracytoplasmic Sperm Injection
after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate ( % )
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blastocyst rate ( % )
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

Ibn Sina Hospital

Collaborators

Banon IVF Center Assiut, Egypt
Al Baraka Fertility Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 18, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IbnSina Oocyte activation

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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