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

NCT ID: NCT01718210

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-12-31

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

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GM-CSF medium

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

Group Type: EXPERIMENTAL

GM-CSF medium

Intervention Type: DRUG

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

CONTROL

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.

Group Type: PLACEBO_COMPARATOR

CONTROL

Intervention Type: DRUG

group of controls treated with a standard IVF medium

Interventions

GM-CSF medium

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

Intervention Type: DRUG

CONTROL

group of controls treated with a standard IVF medium

Intervention Type: DRUG

Other Intervention Names

Embryogen; NORMAL MEDIUM

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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre for Endocrinology and Reproductive Medicine, Italy

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Sbracia, MD

Role: STUDY_CHAIR

Centre for Endocrinology and Reproductive Medicine, Italy

Locations

Villa Salaria Fisiopatologia Riproduzione

Rome, , Italy

Countries

Italy

Other Identifiers

HC0005

Identifier Type: -

Identifier Source: org_study_id