Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media

Not Applicable

Completed

• Conditions: In Vitro Human Embryo Development
• Interventions: Other: No Intervention; Other: Growth Factors and Cytokine adding to embryo culture media

• Registration Number: NCT02426008
• Lead Sponsor: Ibn Sina Hospital

Brief Summary

The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.

Detailed Description

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Study Timeline

• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Study Start: 2015-05-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-29
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 426

Inclusion Criteria

• all patients

Exclusion Criteria

• over 40 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In Vitro culture media	No Intervention	culture media to monitor the embryological outcome as control group
Culture media with growth factors and Cytokine	Growth Factors and Cytokine adding to embryo culture media	Growth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy rate ( % )	3 months

Secondary Outcome Measures

Name	Time	Method
ongoing Pregnancy rate ( % )	6 months
rates of blastocyst formation and quality	6 days of culture

Trial Locations

Locations (1)

Ibnsina IVF center; 🇪🇬 Sohag, Egypt