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

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Unknown; Phase 4

Conditions: IVF; Infertility; Embryo Development

Treatments: Other: Control; Other: G-CSF medium

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02651285

CRH2016/01

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 G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing 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 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

Enrollment: 180 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No 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.)

Trial design

180 participants in 2 patient groups, including a placebo group

G-CSF

Experimental group

Description:

The embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF

Treatment:

Other: G-CSF medium

CONTROL

Placebo Comparator group

Description:

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.

Treatment:

Other: Control