- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399787
Geneexpression as a Marker of Embryo Viability
November 6, 2020 updated by: Kirstine Kirkegaard, University of Aarhus
The aim of the post doc project is investigate which genes regulate implantation in order to analyze specific proteins and microRNA in the spent culture media with the long-term goal of developing a non-invasive method of embryo assessment and selection.
This will be achieved by conducting a targeted NGS analysis, based on list obtained from a non-published pilot study.
When further validated by q-PCR, the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified.
The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential.
If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment.
Study Overview
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aarhus, Denmark, 8200
- The Fertility Clinic, Aarhus University Hospital, Skejby
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Infertile women
Description
Inclusion Criteria:
- >5 oocytes retrieved
Exclusion Criteria:
- endometriosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
infertile patients
Infertile patients with more than 5 oocytes retrieved and no endometriosis
|
Performed on day 5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gene expression
Time Frame: 2 years
|
the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified.
The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential.
If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
March 23, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 26, 2015
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 6, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-10-72-382-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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