NCT01718210

Brief Summary

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may improve the embryo implantation in patients experiencing recurrent implantation failure in IVF cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Typical duration for phase_4

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

March 2, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

March 2, 2012

Last Update Submit

April 25, 2016

Conditions

Infertility

Keywords

GM-CSFrecurrent implantation failurepregnancy rateIVF

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    The number of patients become pregnant after IVF where GM-CSF medium is used, compared with the number of patients become pregnant in the control group

    9 months

Secondary Outcomes (1)

  • Implantation rate

    9 months

Study Arms (2)

GM-CSF medium

EXPERIMENTAL

patient's embryos are incubated after fertilization with mediun supplemented with GM-CSF

Drug: GM-CSF medium

CONTROL

PLACEBO COMPARATOR

50 women with recurrent implantation failure (at leat three previous IVF attempts failed with at least 8 good embryos transferred in uterus)that the obtained with IVF are incubated with a standard medium for IVF, and utilized as control group.

Drug: CONTROL

Interventions

GM-CSF mediumDRUG

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

Also known as: Embryogen
GM-CSF medium
CONTROLDRUG

group of controls treated with a standard IVF medium

Also known as: NORMAL MEDIUM
CONTROL

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • woman age 40 years old or less,
  • or more consecutive previous failed IVF cycles with a total of at least 8 good embryos replaced in uterus

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)

Villa Salaria Fisiopatologia Riproduzione

Rome, 00198, Italy

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marco Sbracia, MD

    Centre for Endocrinology and Reproductive Medicine, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2012

First Posted

October 31, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

IT(1)