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

NCT ID: NCT02651285

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-03-31

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

Conditions

Infertility; Embryo Development; IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

G-CSF

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

Group Type: EXPERIMENTAL

G-CSF medium

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

incubation of IVF embryos with a medium without G-CSF

Interventions

G-CSF medium

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

Intervention Type: OTHER

Control

incubation of IVF embryos with a medium without G-CSF

Intervention Type: OTHER

Other Intervention Names

(granulokine)

Eligibility Criteria

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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre for Endocrinology and Reproductive Medicine, Italy

NETWORK

Sponsor Role: lead

Responsible Party

Fabio Scarpellini

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Morgia, MS

Role: STUDY_CHAIR

Centre for Endocrinology and Reproductive Medicine, Italy

Locations

Cerm-Hungaria

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Sbracia, MD

Role: CONTACT

marcandrea@hotmail.com

+393479037433

Fabio Scarpellini, MD

Role: CONTACT

quelidebercia@hotmail.com

+393278779064

Facility Contacts

MARCO SBRACIA, MD

Role: primary

marcandrea@hotmail.com

+393479037433

FABIO SCARPELLINI, MD

Role: backup

quelidebercia@hotmail.com

+393278779064

Other Identifiers

CRH2016/01

Identifier Type: -

Identifier Source: org_study_id