Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 25 for:    stem cells AND male infertility

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651285
Recruitment Status : Unknown
Verified January 2016 by Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy.
Recruitment status was:  Recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Fabio Scarpellini, 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.

Condition or disease Intervention/treatment Phase
Infertility Embryo Development IVF Other: G-CSF medium Other: Control Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

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 Name: (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




Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: 12 months ]
    The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated

  2. implantation rate [ Time Frame: 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 :
  1. number of blastocyst developped [ Time Frame: 12 months ]
    The number of blastocysts obtained after IVF where G-CSF medium is used divided for the number of fertilized oocytes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651285


Contacts
Layout table for location contacts
Contact: Marco Sbracia, MD +393479037433 marcandrea@hotmail.com
Contact: Fabio Scarpellini, MD +393278779064 quelidebercia@hotmail.com

Locations
Layout table for location information
Italy
Cerm-Hungaria Recruiting
Rome, Italy, 00153
Contact: MARCO SBRACIA, MD    +393479037433    marcandrea@hotmail.com   
Contact: FABIO SCARPELLINI, MD    +393278779064    quelidebercia@hotmail.com   
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
Layout table for investigator information
Study Chair: Francesco Morgia, MS Centre for Endocrinology and Reproductive Medicine, Italy

Layout table for additonal information
Responsible Party: Fabio Scarpellini, Clinical Director, Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT02651285     History of Changes
Other Study ID Numbers: CRH2016/01
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy:
G-CSF
BLASTOCYST
IVF
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs