NCT03953859

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

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 4, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

May 13, 2019

Last Update Submit

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

Genetic: double strand break

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

Gamete donors

Eligibility Criteria

Age21 Years - 42 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

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

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

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

Locations