InfertilityNCT04477863
Follow-up With Preimplantation Genetic Testing Patients
An observational study of Infertility and Genetic Disease, run by Genomic Prediction Inc. at 1 site in United States.
Trial summary
The main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (PGT). Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility, Genetic Disease, IVF
- What is being tested?
- Follow-up Interview
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2020to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who undergo IVF and Preimplantation Genetic Testing
Who may be able to join
- Patients indicating willingness to participate in research during informed consent to perform PGT
Who cannot join
- Patients who opted out of participating in research during informed consent to perform PGT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Genomic Prediction Clinical Laboratory
North Brunswick, New Jersey, 08902
Talia Metzgar, RN, (973) 529-4223, Talia@genomicprediction.com
Bhavini Rana, (973) 529-4223, bhavini@genomicprediction.com
About this study
The main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (PGT). Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded interview.
Read the detailed description
Purpose: To perform longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.
Background: Preimplantation Genetic Testing (PGT) is a commercially available adjunct to in vitro fertilization (IVF) and is now performed in over 40% of treatment cycles in the United Sates (Society for Assisted Reproductive Technology Annual Report, 2018). Several clinical genetics entities offer PGT services, including Genomic Prediction Clinical Laboratory (CLIA# 31D2152380, CAP# 8488628). It is common practice to perform interviews with, and record reviews of patients following clinical interventions. Results may provide instrumental information for the scientific and medical community to improve clinical care. We would like to review medical records in order to recruit patients to participate in longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.
Study Design and Methods: Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. Patients who opted out of participating in research during informed consent to perform PGT will be ineligible for inclusion. Clinical PGT consent forms will be reviewed to identify patients that indicated willingness to participate in research. Eligible patients will be counseled on the study and consented for participation by a licensed genetic counselor. A total of 10,000 patients will be recruited. Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings. As it is in standard practice, all external communication of results will maintain de-identification of all protected health information of all subjects (HIPAA guidelines). A licensed genetic counselor will conduct a recorded interview. Patient PGT, family history, and ethnicity data and information may be included in cohort analyses.
- Conditions
- Infertility, Genetic Disease, IVF
- Being tested
- Follow-up Interview
- Keywords
- PGT, Follow-up
- Medical subject headings
- Infertility, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up InterviewOther
Non Applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perspectives on PGT
Analysis of interview responses
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start11 Jul 2020
- Primary completion11 Jul 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
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
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genomic Prediction Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan R Treff, PhD, Principal investigator, Genomic Prediction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477863
- Sponsor's protocol ID
- Genomic Prediction Inc 609
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2020
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up With Preimplantation Genetic Testing Patients
- ClinicalTrials.gov ID
- NCT04477863
- Acronym / sponsor ID
- Genomic Prediction Inc 609
- Conditions
- Infertility, Genetic Disease, IVF
- Keywords
- PGT, Follow-up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Genomic Prediction Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2020 (actual)
- Primary completion
- 11 Jul 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 20 Jul 2020 (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 main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (PGT). Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded interview.
Detailed description
Purpose: To perform longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.
Background: Preimplantation Genetic Testing (PGT) is a commercially available adjunct to in vitro fertilization (IVF) and is now performed in over 40% of treatment cycles in the United Sates (Society for Assisted Reproductive Technology Annual Report, 2018). Several clinical genetics entities offer PGT services, including Genomic Prediction Clinical Laboratory (CLIA# 31D2152380, CAP# 8488628). It is common practice to perform interviews with, and record reviews of patients following clinical interventions. Results may provide instrumental information for the scientific and medical community to improve clinical care. We would like to review medical records in order to recruit patients to participate in longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.
Study Design and Methods: Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. Patients who opted out of participating in research during informed consent to perform PGT will be ineligible for inclusion. Clinical PGT consent forms will be reviewed to identify patients that indicated willingness to participate in research. Eligible patients will be counseled on the study and consented for participation by a licensed genetic counselor. A total of 10,000 patients will be recruited. Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings. As it is in standard practice, all external communication of results will maintain de-identification of all protected health information of all subjects (HIPAA guidelines). A licensed genetic counselor will conduct a recorded interview. Patient PGT, family history, and ethnicity data and information may be included in cohort analyses.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergo IVF and Preimplantation Genetic Testing
Key inclusion criteria (1 listed)
- Patients indicating willingness to participate in research during informed consent to perform PGT
Key exclusion criteria (1 listed)
- Patients who opted out of participating in research during informed consent to perform PGT
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 |
|---|---|---|
| Follow-up InterviewNon Applicable | Other | – |
Primary outcome
Patient perspectives on PGT
Time frame: 2 years
Analysis of interview responses
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- SART Preliminary National Summary Report for 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings.
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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.
Nathan R Treff, PhD principal investigator
Genomic Prediction
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 and Genetic Disease, run by Genomic Prediction Inc. 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Talia Metzgar, RN ((973) 529-4223, Talia@genomicprediction.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient perspectives on PGT (time frame: 2 years). 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 26 Aug 2025.