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

NCT ID: NCT02420886

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-16
• Study Completion Date: 2016-03-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media

Intervention Type: OTHER

Traditional Single step culture media

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• all patients

Exclusion Criteria

• over 40 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Banon IVF Center Assiut, Egypt

OTHER

Sponsor Role: collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Fawzy

IVF Laboratory Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Banon IVF Center

Asyut, , Egypt

Ibnsina IVF center

Sohag, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 31551154 (View on PubMed)

Other Identifiers

Ibnsina IVF center

Identifier Type: -

Identifier Source: org_study_id