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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02651285
• Other study ID #: CRH2016/01
• Status: Recruiting
• Phase: Phase 4
• First received: January 7, 2016
• Last updated: January 7, 2016
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2016
• Source: Centre for Endocrinology and Reproductive Medicine, Italy
• Contact: Marco Sbracia, MD
• Phone: +393479037433
• Email: marcandrea[@]hotmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Embryo Development
• Infertility
• IVF

Intervention

Other:
• G-CSF medium
incubation of IVF embryos with a specific medium containing G-CSF
• Control
incubation of IVF embryos with a medium without G-CSF

Locations

Country	Name	City	State
Italy	Cerm-Hungaria	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	implantation rate	The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred	12 months	No
Secondary	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	No