NCT02480491

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

June 20, 2015

Last Update Submit

June 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • correlations between levels of measured cell free DNA and embryo quality.

    12 months

Study Arms (2)

Third day embryos

embryos culture media during third day after fertilization

Other: measuring cell freeDNA

Fifth day embryos

embryos culture media during fifth day after fertilization

Other: measuring cell freeDNA

Interventions

measuring cell free DNA using PCR

Fifth day embryosThird day embryos

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICSI Treatment Cycles females

You may qualify if:

  • third day embryos

You may not qualify if:

  • less than third day embryos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

cell free DNA content of the culture medium of the human embryo

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Embryology Lab., Ain Shams Univesity

Study Record Dates

First Submitted

June 20, 2015

First Posted

June 24, 2015

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06