InfertilityNCT06373237
Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A
An observational study of Infertility, run by Inception Fertility Research Institute, LLC at 1 site in United States.
Trial summary
This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 28 Apr 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women of any age who have conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.
Who may be able to join
- Patients that conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.
Who cannot join
- Patients who had multiple embryo transfer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Observation of Outcomes of Embryos Transferred After Initial Chaotic Results on Preimplantation Genetic Testing for Aneuploidy (PGT-A)
This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed.
Read the detailed description
Primary objective: to observe the outcomes of embryos transferred with initial "chaotic" results on PGT-A via Igenomix.
Hypothesis: The transfer of chaotic embryos can result in clinical pregnancy, as defined by fetal heartbeat at 6-8 weeks gestation. Furthermore, these transfers may also result in live birth and expand reproductive potential for patients seeking IVF with PGT-A.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo re-biopsy rate
Frequency of re-biopsy post initial chaotic PGT-A result
Measured: 2 years
Embryo transfer rate
Frequency of embryo transfer post re-biopsy
Measured: 2 years
Pregnancy rate
Frequency of positive serum pregnancy test post embryo transfer of initial chaotic embryo
Measured: 2 years
Live birth rate
Frequency of live birth post embryo transfer of initial chaotic embryo
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 posted18 Apr 2024
- Study start26 Mar 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Igenomix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373237
- Sponsor's protocol ID
- INC-IG-2024-001
- Status last verified
- Jul 2025
- First submitted
- 8 Apr 2024
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observation of Outcomes of Embryos Transferred After Initial Chaotic Results on Preimplantation Genetic Testing for Aneuploidy (PGT-A)
- ClinicalTrials.gov ID
- NCT06373237
- Acronym / sponsor ID
- INC-IG-2024-001
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Igenomix
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 18 Apr 2024 (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.
This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed.
Detailed description
Primary objective: to observe the outcomes of embryos transferred with initial "chaotic" results on PGT-A via Igenomix.
Hypothesis: The transfer of chaotic embryos can result in clinical pregnancy, as defined by fetal heartbeat at 6-8 weeks gestation. Furthermore, these transfers may also result in live birth and expand reproductive potential for patients seeking IVF with PGT-A.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women of any age who have conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.
Key inclusion criteria (1 listed)
- Patients that conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.
Key exclusion criteria (1 listed)
- Patients who had multiple embryo transfer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Embryo re-biopsy rate
Time frame: 2 years
Frequency of re-biopsy post initial chaotic PGT-A result
Embryo transfer rate
Time frame: 2 years
Frequency of embryo transfer post re-biopsy
Pregnancy rate
Time frame: 2 years
Frequency of positive serum pregnancy test post embryo transfer of initial chaotic embryo
Live birth rate
Time frame: 2 years
Frequency of live birth post embryo transfer of initial chaotic 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 20 Jul 2025.
- 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 Inception Fertility Research Institute, LLC 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: finished, as of the sponsor's last update on 20 Jul 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?
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?
Embryo re-biopsy rate (time frame: 2 years). The study lists 4 primary outcomes in all. 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 20 Jul 2025.