NCT02426008

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 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 17, 2015

Last Update Submit

September 29, 2018

Conditions

In Vitro Human Embryo Development

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy rate ( % )

    3 months

Secondary Outcomes (2)

  • ongoing Pregnancy rate ( % )

    6 months

  • rates of blastocyst formation and quality

    6 days of culture

Study Arms (2)

Culture media with growth factors and Cytokine

EXPERIMENTAL

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

In Vitro culture media

PLACEBO COMPARATOR

culture media to monitor the embryological outcome as control group

Other: No Intervention

Interventions

Growth Factors and Cytokine adding to embryo culture mediaOTHER
Culture media with growth factors and Cytokine
No InterventionOTHER

Nothing to Add

In Vitro 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 old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibnsina IVF center

Sohag, Egypt

Location

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 24, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

EG(1)