InfertilityNCT03953859
Embryo DNA Repair Capacity Project
An observational study of Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 42 years
- Conditions the study is for
- Infertility
- What is being tested?
- double strand break
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 9 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- All sexes
- Adult
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
Who may be able to join
- 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
Who cannot join
- less than 21 years of age
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Assoicates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: 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
Read the 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.
- Conditions
- Infertility
- Being tested
- double strand break
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double strand breakGenetic
an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed
| Study group | Role | What they receive |
|---|---|---|
| Gamete donors | healthy male and female game donors to undergo routine gamete donation process Receives: Genetic: double strand break | |
| Infertile Couple | Couples undergoing routine IVF to treat their infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start4 Apr 2019
- Primary completion30 Apr 2020
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953859
- Sponsor's protocol ID
- RMA-UK-01
- Status last verified
- Jan 2022
- First submitted
- 13 May 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos
- ClinicalTrials.gov ID
- NCT03953859
- Acronym / sponsor ID
- RMA-UK-01
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mail aim of the present study is to use molecular methods to analyze the ability of human preimplantation embryos to repair their DNA
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamete donors | – | Genetic: double strand breakhealthy male and female game donors to undergo routine gamete donation process |
| Infertile Couple | – | –Couples undergoing routine IVF to treat their infertility |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- less than 21 years of age
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double strand breakan induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed | Genetic | Gamete donors |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
repair of double strand break in DNA (time frame: up to 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.