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

Phase 4

• Conditions: Infertility; Embryo Development; IVF
• Interventions: Other: G-CSF medium; Other: Control

• Registration Number: NCT02651285
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

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

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-08
• Last Update Posted: 2016-01-08
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF	G-CSF medium	The embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF
CONTROL	Control	The embryos obtained by women undergoing IVF included in this arm will be incubated with a standard medium for IVF, and utilized as control group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cerm-Hungaria; 🇮🇹 Rome, Italy