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

Growth Factors Supplementation to Single-Step Culture Medium

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 426
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • IbnSina IVF Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• all patients

Exclusion Criteria:

• over 40 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culture media with growth factors and Cytokine; Growth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome.	Other: Growth Factors and Cytokine adding to embryo culture media
Placebo Comparator: In Vitro culture media; culture media to monitor the embryological outcome as control group	Other: No Intervention; Nothing to Add

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Pregnancy rate ( % )	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
ongoing Pregnancy rate ( % )	6 months
rates of blastocyst formation and quality	6 days of culture

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 24, 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

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: IbnSina IVF