Embryo DNA Repair Capacity Project
Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos
1 other identifier
observational
6
1 country
1
Brief Summary
The mail aim of the present study is to use molecular methods to analyze the ability of human preimplantation embryos to repair their DNA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2021
CompletedJanuary 14, 2022
January 1, 2022
1.1 years
May 13, 2019
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
repair of double strand break in DNA
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
Study Arms (2)
Gamete donors
healthy male and female game donors to undergo routine gamete donation process
Infertile Couple
Couples undergoing routine IVF to treat their infertility
Interventions
an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed
Eligibility Criteria
Healthy volunteer subjects will be recruiting from amongst the gamete donor population and patients undergoing in vitro fertilization (IVF) for treatment of their infertility
You may qualify if:
- 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
You may not qualify if:
- less than 21 years of age
- inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive Medicine Assoicates of New Jersey
Basking Ridge, New Jersey, 07920, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 17, 2019
Study Start
April 4, 2019
Primary Completion
April 30, 2020
Study Completion
December 9, 2021
Last Updated
January 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share