Abnormal FertilizationNCT07666243
Outcomes of Embryos Created From Abnormally Fertilized Oocytes
An observational study of Abnormal Fertilization and Infertility, run by Inception Fertility Research Institute, LLC.
Trial summary
The purpose of this study is to retrospectively analyze data from multiple clinics in a fertility network on embryos that were created from abnormally fertilized oocytes (AFO) including the rate of transfers and any clinical outcomes in order to inform providers in their decision making regarding AFOs. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abnormal Fertilization, Infertility
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2027
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Females of varying age, race, and ethnicity who underwent in vitro fertilization which resulted in a blastocyst derived from an abnormally fertilized embryo
Who may be able to join
- Underwent in vitro fertilization which resulted in a blastocyst derived from an abnormally fertilized embryo
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to retrospectively analyze data from multiple clinics in a fertility network on embryos that were created from abnormally fertilized oocytes (AFO) including the rate of transfers and any clinical outcomes in order to inform providers in their decision making regarding AFOs.
- Conditions
- Abnormal Fertilization, Infertility
- Keywords
- Fertility, Reproductive Medicine
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
For blastocysts derived from AFOs that were transferred, clinical outcomes include implantation rate, ongoing pregnancy rate, live birth rate, and spontaneous abortion rate.
Measured: From embryo transfer to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abnormal FertilizationStudies 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
- 92 participants (estimated)
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
- NCT07666243
- Sponsor's protocol ID
- IRI-AFO-2026-001
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hondo S, Arichi A, Muramatsu H, Omura N, Ito K, Komine H, Monzen S, Mukai N, Endo M, Katase S, Kidera N, Sasaki H, Koi H, Yorimitsu T, Ohara M, Kawamura T, Shimizu Y. Clinical outcomes of transfer of frozen and thawed single blastocysts derived from nonpronuclear and monopronuclear zygotes. Reprod Med Biol. 2019 May 15;18(3):278-283. doi: 10.1002/rmb2.12275. eCollection 2019 Jul.
PubMed 31312107Kemper JM, Liu Y, Afnan M, Mol BWJ, Morbeck DE. What happens to abnormally fertilized embryos? A scoping review. Reprod Biomed Online. 2023 May;46(5):802-807. doi: 10.1016/j.rbmo.2023.02.005. Epub 2023 Feb 22.
PubMed 36997399Al Hashimi B, Harvey SC, Harvey KE, Linara-Demakakou E, Raikundalia B, Green O, Griffin DK, Ahuja K, Macklon N. Reassessing the conventional fertilization check: leveraging preimplantation genetic testing for aneuploidy to increase the number of transferrable embryos. Reprod Biomed Online. 2025 Jun;50(6):104595. doi: 10.1016/j.rbmo.2024.104595. Epub 2024 Oct 24.
PubMed 40262446Mutia K, Wiweko B, Iffanolida PA, Febri RR, Muna N, Riayati O, Jasirwan SO, Yuningsih T, Mansyur E, Hestiantoro A. The Frequency of Chromosomal Euploidy Among 3PN Embryos. J Reprod Infertil. 2019 Jul-Sep;20(3):127-131.
PubMed 31423415Girardi L, Patassini C, Miravet Valenciano J, Sato Y, Fagundes Cagnin N, Castellon JA, Cogo F, Zambon P, Blesa D, Jimenez Almazan J, Akinwole A, Coprerski B, Rubio C. Incidence of haploidy and triploidy in trophectoderm biopsies of blastocysts derived from normally and abnormally fertilized oocytes. J Assist Reprod Genet. 2024 Dec;41(12):3357-3370. doi: 10.1007/s10815-024-03278-4. Epub 2024 Oct 8.
PubMed 39378000Ezoe K, Takahashi T, Shimazaki K, Miki T, Tanimura Y, Amagai A, Sawado A, Akaike H, Mogi M, Kaneko S, Kato M, Kato K, Tarozzi N, Borini A, Coticchio G. Human 1PN and 3PN zygotes recapitulate all morphokinetic events of normal fertilization but reveal novel developmental errors. Hum Reprod. 2022 Sep 30;37(10):2307-2319. doi: 10.1093/humrep/deac177.
PubMed 35950593Canon C, Thurman A, Li A, Hernandez-Nieto C, Lee JA, Roth RM, Slifkin R, Briton-Jones C, Stein D, Copperman AB. Assessing the clinical viability of micro 3 pronuclei zygotes. J Assist Reprod Genet. 2023 Jul;40(7):1765-1772. doi: 10.1007/s10815-023-02830-y. Epub 2023 May 25.
PubMed 37227570
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Embryos Created From Abnormally Fertilized Oocytes
- ClinicalTrials.gov ID
- NCT07666243
- Acronym / sponsor ID
- IRI-AFO-2026-001
- Conditions
- Abnormal Fertilization, Infertility
- Keywords
- Fertility, Reproductive Medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Igenomix
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jun 2026 (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 purpose of this study is to retrospectively analyze data from multiple clinics in a fertility network on embryos that were created from abnormally fertilized oocytes (AFO) including the rate of transfers and any clinical outcomes in order to inform providers in their decision making regarding AFOs.
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
- Females of varying age, race, and ethnicity who underwent in vitro fertilization which resulted in a blastocyst derived from an abnormally fertilized embryo
Key inclusion criteria (1 listed)
- Underwent in vitro fertilization which resulted in a blastocyst derived from an abnormally fertilized embryo
Key exclusion criteria (0 listed)
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
Clinical Outcomes
Time frame: From embryo transfer to delivery
For blastocysts derived from AFOs that were transferred, clinical outcomes include implantation rate, ongoing pregnancy rate, live birth rate, and spontaneous abortion rate.
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 24 Jun 2026.
- Background: PubMed 31312107Hondo S, Arichi A, Muramatsu H, Omura N, Ito K, Komine H, Monzen S, Mukai N, Endo M, Katase S, Kidera N, Sasaki H, Koi H, Yorimitsu T, Ohara M, Kawamura T, Shimizu Y. Clinical outcomes of transfer of frozen and thawed single blastocysts derived from nonpronuclear and monopronuclear zygotes. Reprod Med Biol. 2019 May 15;18(3):278-283. doi: 10.1002/rmb2.12275. eCollection 2019 Jul.
- Background: PubMed 36997399Kemper JM, Liu Y, Afnan M, Mol BWJ, Morbeck DE. What happens to abnormally fertilized embryos? A scoping review. Reprod Biomed Online. 2023 May;46(5):802-807. doi: 10.1016/j.rbmo.2023.02.005. Epub 2023 Feb 22.
- Background: PubMed 40262446Al Hashimi B, Harvey SC, Harvey KE, Linara-Demakakou E, Raikundalia B, Green O, Griffin DK, Ahuja K, Macklon N. Reassessing the conventional fertilization check: leveraging preimplantation genetic testing for aneuploidy to increase the number of transferrable embryos. Reprod Biomed Online. 2025 Jun;50(6):104595. doi: 10.1016/j.rbmo.2024.104595. Epub 2024 Oct 24.
- Background: PubMed 31423415Mutia K, Wiweko B, Iffanolida PA, Febri RR, Muna N, Riayati O, Jasirwan SO, Yuningsih T, Mansyur E, Hestiantoro A. The Frequency of Chromosomal Euploidy Among 3PN Embryos. J Reprod Infertil. 2019 Jul-Sep;20(3):127-131.
- Background: PubMed 39378000Girardi L, Patassini C, Miravet Valenciano J, Sato Y, Fagundes Cagnin N, Castellon JA, Cogo F, Zambon P, Blesa D, Jimenez Almazan J, Akinwole A, Coprerski B, Rubio C. Incidence of haploidy and triploidy in trophectoderm biopsies of blastocysts derived from normally and abnormally fertilized oocytes. J Assist Reprod Genet. 2024 Dec;41(12):3357-3370. doi: 10.1007/s10815-024-03278-4. Epub 2024 Oct 8.
- Background: PubMed 35950593Ezoe K, Takahashi T, Shimazaki K, Miki T, Tanimura Y, Amagai A, Sawado A, Akaike H, Mogi M, Kaneko S, Kato M, Kato K, Tarozzi N, Borini A, Coticchio G. Human 1PN and 3PN zygotes recapitulate all morphokinetic events of normal fertilization but reveal novel developmental errors. Hum Reprod. 2022 Sep 30;37(10):2307-2319. doi: 10.1093/humrep/deac177.
- Background: PubMed 37227570Canon C, Thurman A, Li A, Hernandez-Nieto C, Lee JA, Roth RM, Slifkin R, Briton-Jones C, Stein D, Copperman AB. Assessing the clinical viability of micro 3 pronuclei zygotes. J Assist Reprod Genet. 2023 Jul;40(7):1765-1772. doi: 10.1007/s10815-023-02830-y. Epub 2023 May 25.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Fertilization and Infertility, run by Inception Fertility Research Institute, LLC.
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 0 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Laurel Anderson, BS (3463621476, landerson@inceptionllc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcomes (time frame: From embryo transfer to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07666243, which also lists 7 linked publications.
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 24 Jun 2026.