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

Infertility Clinical Trial

— CISC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418416
• Other study ID #: IbnSina Hospital IVF
• Status: Completed
• Phase: N/A
• Start date: May 6, 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2018
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• poor sperm

• poor quality Oocytes

• previous failed fertilization

• previous poor embryogenesis

Exclusion Criteria:

• normal patient

• previous successful outcome

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Oocyte double chemical activation
Oocyte double chemical activation

Locations

Country	Name	City	State
Bahrain	Al Barka fertility center	Bahrain
Egypt	Banon fertility center	Assiut
Egypt	IbnSina IVF unit, IbnSina Hospital, El Areef Square	Sohag

Sponsors (3)

Lead Sponsor	Collaborator
Ibn Sina Hospital	Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt

Countries where clinical trial is conducted

Bahrain,  Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy rate ( % )	To predict percentage of pregnant women from those will undergo Embryo transfer	3 months
Secondary	Blastocyst rate ( % )	Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection	3 months