Artificial Oocyte Activation Comparing Tow Different Agents

Not Applicable

Completed

• Conditions: Oocyte Fertilization
• Interventions: Other: Artificial Oocyte activation; Drug: Strontium Chloride; Drug: Ca Ionophore

• Registration Number: NCT02424214
• Lead Sponsor: Ibn Sina Hospital

Brief Summary

Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-18
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• previous fertilization failure
• poor quality Oocytes
• poor sperms

Exclusion Criteria

• normal patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strontium Chloride group	Artificial Oocyte activation	Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection
Strontium Chloride group	Strontium Chloride	Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection
Ca Ionophore group	Artificial Oocyte activation	Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection
Ca Ionophore group	Ca Ionophore	Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection

Primary Outcome Measures

Name	Time	Method
Pregnancy rate ( % )	9 months

Secondary Outcome Measures

Name	Time	Method
Blastocyst rate ( % )	9 months

Trial Locations

Locations (3)

Banon Fertility Center; 🇪🇬 Assiut, Egypt

Al Barka fertility center; 🇧🇭 Manama, Bahrain

Ibnsina IVF center; 🇪🇬 Sohag, Egypt