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Embryo DNA Repair Capacity Project

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ClinicalTrials.gov Identifier: NCT03953859
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

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

Condition or disease Intervention/treatment
Infertility Genetic: double strand break

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
Gamete donors
healthy male and female game donors to undergo routine gamete donation process
Genetic: double strand break
an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed

Infertile Couple
Couples undergoing routine IVF to treat their infertility



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   21 Years to 42 Years   (Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953859


Contacts
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Contact: Christine V Whitehead, BSN, RN 973-656-2841 clinicalresearchteam@ivirma.com
Contact: Caroline Zuckerman, BS 973-656-2841 clinicalresearchteam@ivirma.com

Locations
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United States, New Jersey
Reproductive Medicine Assoicates of New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christine V Whitehead, BSN,RN    973-656-2841    clinicalresearchteam@rmanj.com   
Contact: Caroline Zuckerman, BS    973-656-2841    clinicalresearchteam@ivirma.com   
Principal Investigator: Richard T Scott, MD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey

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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT03953859     History of Changes
Other Study ID Numbers: RMA-UK-01
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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