NCT02422134

Brief Summary

It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

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

Study Start

First participant enrolled

June 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

April 16, 2015

Last Update Submit

June 28, 2016

Conditions

Infertility

Keywords

PregnancyimplantationCytokine

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate ( % )

    9 months

Secondary Outcomes (1)

  • Implantation rate ( % )

    9 months

Study Arms (2)

Cytokine plus Hyalurinan embryo transfer arm

ACTIVE COMPARATOR

To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.

Other: Cytokine group

Hyalurinan embryo transfer group

NO INTERVENTION

To transfer the embryos using a Hyaluronan enriched medium only

Interventions

Cytokine groupOTHER

Testing the efficacy of adding Cytokine to embryo transfer medium

Cytokine plus Hyalurinan embryo transfer arm

Eligibility Criteria

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

You may qualify if:

  • all patients

You may not qualify if:

  • above 40 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banon IVF center

Asyut, Egypt

Location

Ibnsina IVF center

Sohag, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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 16, 2015

First Posted

April 21, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

EG(2)