Artificial Oocyte Activation Comparing Tow Different Agents

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02424214
• Collaborator: Al Baraka Fertility Hospital (Other), Banon IVF Center Assiut, Egypt (Other)
• Enrollment: 450
• Locations: 3
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site: 150
• Patients Per Site Per Month: 16.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oocyte Fertilization	Other: Artificial Oocyte activation; Drug: Ca Ionophore; Drug: Strontium Chloride	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pregnancy rate ( % ) [9 months]

Secondary Outcome Measures

1. Blastocyst rate ( % ) [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• previous fertilization failure

• poor quality Oocytes

• poor sperms

Exclusion Criteria:

• normal patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Barka fertility center	Manama		Bahrain
2	Banon Fertility Center	Assiut		Egypt
3	Ibnsina IVF center	Sohag		Egypt

Sponsors and Collaborators

• Ibn Sina Hospital
• Al Baraka Fertility Hospital
• Banon IVF Center Assiut, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT02424214
• Other Study ID Numbers: IbnSina Oocyte activation
• First Posted: Apr 22, 2015
• Last Update Posted: Feb 19, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Ionophores

Study Results

No Results Posted as of Feb 19, 2018