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

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02418416
• Collaborator: Al Baraka Fertility Hospital (Other), Banon IVF Center Assiut, Egypt (Other)
• Enrollment: 400
• Locations: 3
• Arms: 2
• Actual Duration (Months): 12.9
• Patients Per Site: 133.3
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Oocyte double chemical activation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development
• Actual Study Start Date: May 6, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical Pregnancy rate ( % ) [3 months]

   To predict percentage of pregnant women from those will undergo Embryo transfer

Secondary Outcome Measures

1. Blastocyst rate ( % ) [3 months]

   Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• poor sperm

• poor quality Oocytes

• previous failed fertilization

• previous poor embryogenesis

Exclusion Criteria:

• normal patient

• previous successful outcome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Barka fertility center	Bahrain		Bahrain
2	Banon fertility center	Assiut		Egypt
3	IbnSina IVF unit, IbnSina Hospital, El Areef Square	Sohag		Egypt	12345

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 Laboratory Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT02418416
• Other Study ID Numbers: IbnSina Hospital IVF
• First Posted: Apr 16, 2015
• Last Update Posted: Sep 27, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Sep 27, 2018