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

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: CONTROL; Drug: GM-CSF medium

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01718210

HC0005

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

GM-CSF medium

Experimental group

Description:

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

Treatment:

Drug: GM-CSF medium

CONTROL

Placebo Comparator group

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.

Treatment:

Drug: CONTROL