Embryo DNA Repair Capacity Project
January 13, 2022 updated by: Reproductive Medicine Associates of New Jersey
Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos
The mail aim of the present study is to use molecular methods to analyze the ability of human preimplantation embryos to repair their DNA
Study Overview
Detailed Description
The main aim of the present study is to investigate the DNA repair pathways of preimplantation embryos, examining the events that take place following induction of a DSB at a unique targeted site.
The investigators aim to address questions concerning the functionality of the DNA repair mechanism(s) in developing embryos, before and after genome activation.
Study Type
Observational
Enrollment (Actual)
6
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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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Reproductive Medicine Assoicates of New Jersey
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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
21 years to 42 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteer subjects will be recruiting from amongst the gamete donor population and patients undergoing in vitro fertilization (IVF) for treatment of their infertility
Description
Inclusion Criteria:
- gamete donors: be at least 21 years of age, in good health and eligible to donate their games through the standard gamete donation programs
- IVF couples: any couples proceeding with a routine IVF cycle
Exclusion Criteria:
- less than 21 years of age
- inability to provide informed consent
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 |
|---|---|
|
Gamete donors
healthy male and female game donors to undergo routine gamete donation process
|
an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed
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Infertile Couple
Couples undergoing routine IVF to treat their infertility
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
repair of double strand break in DNA
Time Frame: up to 12 days
|
targeted deep sequencing to identify the presence of the double strand break in the DNA and subsequent repair ability of the embryo
|
up to 12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
April 4, 2019
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
December 9, 2021
Study Registration Dates
First Submitted
May 13, 2019
First Submitted That Met QC Criteria
May 15, 2019
First Posted (Actual)
May 17, 2019
Study Record Updates
Last Update Posted (Actual)
January 14, 2022
Last Update Submitted That Met QC Criteria
January 13, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMA-UK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.