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

The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media

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 Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Banon IVF center
  • Sohag, Egypt
    • IbnSina IVF Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• all patients

Exclusion Criteria:

• over 40 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cytokines supplemented In Vitro single culture media; We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy.	Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media
No Intervention: Traditional Single step culture media

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ongoing pregnancy rate ( % )	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Collaborators: Banon IVF Center Assiut, Egypt

Publications and helpful links

General Publications

• Fawzy M, Emad M, Elsuity MA, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Sabry M, Nour M, Rasheed SM. Cytokines hold promise for human embryo culture in vitro: results of a randomized clinical trial. Fertil Steril. 2019 Nov;112(5):849-857.e1. doi: 10.1016/j.fertnstert.2019.07.012. Epub 2019 Sep 21.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 29, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: In Vitro culture of human embryos
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Ibnsina IVF center