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

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02420886
• Collaborator: Banon IVF Center Assiut, Egypt (Other)
• Enrollment: 443
• Locations: 2
• Arms: 2
• Actual Duration (Months): 9.5
• Patients Per Site: 221.5
• Patients Per Site Per Month: 23.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 443 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro
• Actual Study Start Date: May 16, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ongoing pregnancy rate ( % ) [6 months]

Secondary Outcome Measures

1. clinical pregnancy rate ( % ) [6 months]

2. implantation rate [6 months]

3. fertilization rate [6 days of culture]

4. top-quality embryo rate [6 days of culture]

5. rates for blastocyst formation and quality [6 days of culture]

6. embryo utilization rate [6 days of culture]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• all patients

Exclusion Criteria:

• over 40 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon IVF Center	Assiut		Egypt
2	Ibnsina IVF center	Sohag		Egypt

Sponsors and Collaborators

• Ibn Sina 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: NCT02420886
• Other Study ID Numbers: Ibnsina IVF center
• First Posted: Apr 20, 2015
• Last Update Posted: Oct 2, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital: In Vitro culture of human embryos
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Oct 2, 2018