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

Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Oocyte double chemical activation

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bahrain
  • Bahrain, Bahrain
    • Al Barka fertility center
• Egypt
  • Assiut, Egypt
    • Banon Fertility Center
  • Sohag, Egypt, 12345
    • IbnSina IVF unit, IbnSina Hospital, El Areef Square

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• normal patient
• previous successful outcome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double 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.	Other: Oocyte double chemical activation; Oocyte double chemical activation
No Intervention: Control arm; The Oocytes will undergo Intracytoplasmic sperm injection only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy rate ( % )	To predict percentage of pregnant women from those will undergo Embryo transfer	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastocyst rate ( % )	Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection	3 months

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Collaborators: Banon IVF Center Assiut, Egypt; Al Baraka Fertility Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IbnSina Hospital IVF