Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media

• Registration Number: NCT02420886
• Lead Sponsor: Ibn Sina Hospital

Brief Summary

Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis and implantation outcomes.

Detailed Description

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth factor that have multi-ways to 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 two arm of the same culture media and the same culture condition. One arm with Cytokines and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Study Timeline

• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-20
• Study Start: 2015-05-16
• 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: 443

Inclusion Criteria

• all patients

Exclusion Criteria

• over 40 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytokines supplemented In Vitro single culture media	Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media	We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy.

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rate ( % )	6 months

Secondary Outcome Measures

Name	Time	Method
top-quality embryo rate	6 days of culture
rates for blastocyst formation and quality	6 days of culture
clinical pregnancy rate ( % )	6 months
implantation rate	6 months
fertilization rate	6 days of culture
embryo utilization rate	6 days of culture

Trial Locations

Locations (2)

Ibnsina IVF center; 🇪🇬 Sohag, Egypt

Banon IVF Center; 🇪🇬 Assiut, Egypt