NCT02651285

Brief Summary

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing IVF cycles.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 7, 2016

Last Update Submit

January 7, 2016

Conditions

InfertilityEmbryo DevelopmentIVF

Keywords

G-CSFBLASTOCYSTIVF

Outcome Measures

Primary Outcomes (2)

  • pregnancy rate

    The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated

    12 months

  • implantation rate

    The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred

    12 months

Secondary Outcomes (1)

  • number of blastocyst developped

    12 months

Study Arms (2)

G-CSF

EXPERIMENTAL

The embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF

Other: G-CSF medium

CONTROL

PLACEBO COMPARATOR

The embryos obtained by women undergoing IVF included in this arm will be incubated with a standard medium for IVF, and utilized as control group.

Other: Control

Interventions

G-CSF mediumOTHER

incubation of IVF embryos with a specific medium containing G-CSF

Also known as: (granulokine)
G-CSF
ControlOTHER

incubation of IVF embryos with a medium without G-CSF

CONTROL

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertility
  • healthy condition,
  • good ovarian reserve (AMH levels more than 1microg/ml)

You may not qualify if:

  • chromosomal defects in the couple,
  • metabolic diseases (diabetes, etc),
  • other genetic diseases (thalassemia, cystic fibrosis, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerm-Hungaria

Rome, 00153, Italy

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Francesco Morgia, MS

    Centre for Endocrinology and Reproductive Medicine, Italy

    STUDY CHAIR

Central Study Contacts

Marco Sbracia, MD

CONTACT

+393479037433marcandrea@hotmail.com

Fabio Scarpellini, MD

CONTACT

+393278779064quelidebercia@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

January 8, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

Locations

IT(1)