Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Oocyte double chemical activation

• Registration Number: NCT02418416
• Lead Sponsor: Ibn Sina Hospital

Brief Summary

Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

Detailed Description

In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.

We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.

Study Timeline

• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Study Start: 2015-05-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• poor sperm
• poor quality Oocytes
• previous failed fertilization
• previous poor embryogenesis

Exclusion Criteria

• normal patient
• previous successful outcome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double activation	Oocyte double chemical activation	The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy rate ( % )	3 months	To predict percentage of pregnant women from those will undergo Embryo transfer

Secondary Outcome Measures

Name	Time	Method
Blastocyst rate ( % )	3 months	Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection

Trial Locations

Locations (3)

Al Barka fertility center; 🇧🇭 Bahrain, Bahrain

Banon fertility center; 🇪🇬 Assiut, Egypt

IbnSina IVF unit, IbnSina Hospital, El Areef Square; 🇪🇬 Sohag, Egypt