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

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

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.

Study Overview

• Status: Unknown
• Conditions: Infertility; Embryo Development; IVF
• Intervention / Treatment: Other: G-CSF medium; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: MARCO SBRACIA, MD; Phone Number: +393479037433; Email: marcandrea@hotmail.com
• Study Contact Backup: Name: FABIO SCARPELLINI, MD; Phone Number: +393278779064; Email: quelidebercia@hotmail.com

Study Locations

• Italy
  • Rome, Italy, 00153
    • Recruiting
    • Cerm-Hungaria
    • Contact: MARCO SBRACIA, MD; Phone Number: +393479037433; Email: marcandrea@hotmail.com
    • Contact: FABIO SCARPELLINI, MD; Phone Number: +393278779064; Email: quelidebercia@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G-CSF; The embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF	Other: G-CSF medium; incubation of IVF embryos with a specific medium containing G-CSF; Other Names: (granulokine)
Placebo Comparator: 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.	Other: Control; incubation of IVF embryos with a medium without G-CSF

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
• Investigators: Study Chair: Francesco Morgia, MS, Centre for Endocrinology and Reproductive Medicine, Italy

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: IVF; G-CSF; BLASTOCYST
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: CRH2016/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES