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Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
GM-CSF medium
CONTROL
Sponsored by
Centre for Endocrinology and Reproductive Medicine, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring GM-CSF, recurrent implantation failure, pregnancy rate, IVF

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Villa Salaria Fisiopatologia Riproduzione

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GM-CSF medium

CONTROL

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Implantation rate
number of embryos implanted

Full Information

First Posted
March 2, 2012
Last Updated
April 25, 2016
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01718210
Brief Title
Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure
Official Title
GM-CSF Supplemented Medium for IVF Embryo Growth in Patients With Recurrent Implantation Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular there are a group of patients, in young reproductive age, experiencing recurrent implantation failure, nevertheless the good embryos produced and transferred. Recently, it has been showed that culture medium supplemented with GM-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients experiencing recurrent implantation failure. 100 women with recurrent implantation failure, at least three failed previous IVF attempts with at least 8 good embryos transferred no more than 40 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the GM-CSF supplemented culture medium (EmbryoGen, Origio, Denmark), or in normal culture in micro drop of 30microliters under oil until the day of transfer (day three or 8 cells sage embryos). A maximum of three embryos will be transferred. The pregnancy rate the implantation rate will be the outcomes considered

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GM-CSF, recurrent implantation failure, pregnancy rate, IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GM-CSF medium
Arm Type
Experimental
Arm Description
patient's embryos are incubated after fertilization with mediun supplemented with GM-CSF
Arm Title
CONTROL
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GM-CSF medium
Other Intervention Name(s)
Embryogen
Intervention Description
incubation of IVF embryos with a specific medium containing GM-CSF
Intervention Type
Drug
Intervention Name(s)
CONTROL
Other Intervention Name(s)
NORMAL MEDIUM
Intervention Description
group of controls treated with a standard IVF medium
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Implantation rate
Description
number of embryos implanted
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: woman age 40 years old or less, 3 or more consecutive previous failed IVF cycles with a total of at least 8 good embryos replaced in uterus Exclusion Criteria: chromosomal defects in the couple, metabolic diseases (diabetes, etc), other genetic diseases (thalassemia, cystic fibrosis, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Sbracia, MD
Organizational Affiliation
Centre for Endocrinology and Reproductive Medicine, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Villa Salaria Fisiopatologia Riproduzione
City
Rome
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure

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