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Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment

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ClinicalTrials.gov Identifier: NCT02480491
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Azza Awad Abdel Razik Mohamed, Sadat City University

Brief Summary:
Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.

Condition or disease Intervention/treatment
Infertility Other: measuring cell freeDNA

Detailed Description:
The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Official Title: Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in ICSI Treatment Cycles
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Group/Cohort Intervention/treatment
Third day embryos
embryos culture media during third day after fertilization
Other: measuring cell freeDNA
measuring cell free DNA using PCR

Fifth day embryos
embryos culture media during fifth day after fertilization
Other: measuring cell freeDNA
measuring cell free DNA using PCR




Primary Outcome Measures :
  1. correlations between levels of measured cell free DNA and embryo quality. [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
cell free DNA content of the culture medium of the human embryo


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ICSI Treatment Cycles females
Criteria

Inclusion Criteria:

  • third day embryos

Exclusion Criteria:

  • less than third day embryos

Responsible Party: Azza Awad Abdel Razik Mohamed, Director of Embryology Lab., Ain Shams Univesity, Sadat City University
ClinicalTrials.gov Identifier: NCT02480491     History of Changes
Other Study ID Numbers: SCS-1
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female