Use of G-CSF Supplemented IVF Medium in Patients Undergoing IVF

G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02651285

Enrollment

180

Registered

2016-01-08

Start date

2016-01-31

Completion date

2017-03-31

Last updated

2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Development, Infertility, IVF

Keywords

G-CSF, BLASTOCYST, IVF

Brief summary

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing 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 also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-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 undergoing IVF. 180 infertile women undergoing IVF no more than 37 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 G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered

Interventions

OTHERG-CSF medium

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

OTHERControl

incubation of IVF embryos with a medium without G-CSF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 38 Years

Healthy volunteers

Inclusion criteria

* infertility * healthy condition, * good ovarian reserve (AMH levels more than 1microg/ml)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
pregnancy rate	12 months	The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated
implantation rate	12 months	The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred

Secondary

Measure	Time frame	Description
number of blastocyst developped	12 months	The number of blastocysts obtained after IVF where G-CSF medium is used divided for the number of fertilized oocytes

Countries

Italy

Contacts

Primary ContactMarco Sbracia, MD

marcandrea@hotmail.com+393479037433

Backup ContactFabio Scarpellini, MD

quelidebercia@hotmail.com+393278779064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026