NCT02420886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

May 16, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

April 15, 2015

Last Update Submit

September 29, 2018

Conditions

Infertility

Keywords

In Vitro culture of human embryos

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate ( % )

    6 months

Secondary Outcomes (6)

  • clinical pregnancy rate ( % )

    6 months

  • implantation rate

    6 months

  • fertilization rate

    6 days of culture

  • top-quality embryo rate

    6 days of culture

  • rates for blastocyst formation and quality

    6 days of culture

  • +1 more secondary outcomes

Study Arms (2)

Cytokines supplemented In Vitro single culture media

ACTIVE COMPARATOR

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

Traditional Single step culture media

NO INTERVENTION

Interventions

Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture mediaOTHER
Cytokines supplemented In Vitro single culture media

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all patients

You may not qualify if:

  • over 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banon IVF Center

Asyut, Egypt

Location

Ibnsina IVF center

Sohag, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31551154DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Heparin-binding EGF-like Growth Factor

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EGF Family of ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Laboratory Director

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 20, 2015

Study Start

May 16, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

EG(2)