NCT07666243

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 Progress17%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 1, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

FertilityReproductive Medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    From embryo transfer to delivery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Underwent in vitro fertilization which resulted in a blastocyst derived from an abnormally fertilized embryo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 31312107BACKGROUND
  • Kemper 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.

    PMID: 36997399BACKGROUND
  • Al 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.

    PMID: 40262446BACKGROUND
  • Mutia 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.

    PMID: 31423415BACKGROUND
  • Girardi 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.

    PMID: 39378000BACKGROUND
  • Ezoe 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.

    PMID: 35950593BACKGROUND
  • Canon 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.

    PMID: 37227570BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Laurel Anderson, BS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 24, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share