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OpenTrials
Completed

NCT Number: NCT01718210

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Villa Salaria Fisiopatologia Riproduzione

Rome, 00198, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

GM-CSF medium

Drug

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

Other names: Embryogen

Control

Drug

group of controls treated with a standard IVF medium

Other names: NORMAL MEDIUM

Primary outcomes

  1. Pregnancy rate

    Time frame: 9 months

    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 outcomes

  1. Implantation rate

    Time frame: 9 months

    number of embryos implanted

Sponsors and collaborators

Lead sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Network

Registry information

Official study title

GM-CSF Supplemented Medium for IVF Embryo Growth in Patients With Recurrent Implantation Failure

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2012
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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