NCT07833345

Brief Summary

This single-center prospective randomized controlled study will enroll 500 infertile women aged 35 years or older who meet the criteria for fresh day-5 single-blastocyst transfer. Participants will be allocated 1:1 to AI-assisted morphological assessment using EmbryoInsights™ or AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus. The study evaluates whether adding euploidy prediction improves ongoing pregnancy after the first fresh transfer. Secondary outcomes are clinical pregnancy, early miscarriage and live birth. Maternal and infant safety will be monitored.

Trial Health

63
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Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Dec 2029

Study Start

First participant enrolled

September 10, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Female Infertility

Keywords

Female InfertilityAdvanced Maternal AgeEmbryonic Aneuploidy

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Ongoing pregnancy is defined as pregnancy reaching 12 weeks of gestation after transfer, with fetal cardiac activity confirmed by ultrasound. The ongoing pregnancy rate is the proportion of transfer cycles in the group that achieve ongoing pregnancy. This outcome is the sole basis for sample size estimation in this study. Assessment: ultrasound at 12 weeks of gestation ±7 days.

    From enrollment to 12 weeks of gestation ±7 days

Secondary Outcomes (3)

  • Clinical pregnancy rate

    From enrollment to 35 days after transfer.

  • Early miscarriage rate

    From confirmation of clinical pregnancy to 12 weeks of gestation

  • Live birth rate

    At delivery

Study Arms (2)

Control

SHAM COMPARATOR

EmbryoInsights™ for AI-assisted morphological assessment

Other: AI-assisted morphological assessment using EmbryoInsights™

Experimental

EXPERIMENTAL

EmbryoInsights™ Plus for morphological assessment combined with euploidy probability prediction

Other: AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus

Interventions

AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ PlusOTHER

AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus

Experimental
AI-assisted morphological assessment using EmbryoInsights™OTHER

AI-assisted morphological assessment using EmbryoInsights™

Control

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Infertile women aged ≥35 years. (2) Planned IVF or ICSI. (3) No more than two previous oocyte-retrieval cycles. (4) At least three usable day-3 embryos and eligibility for day-5 single-blastocyst transfer. (5) At least one day-5 blastocyst meeting transfer criteria, Gardner grade ≥3BB. (6) Voluntary written informed consent from both partners.

You may not qualify if:

  • (1) PGT required because of chromosomal abnormalities. (2) Donor-oocyte, donor-sperm or thawed-oocyte cycles. (3) Severe uterine malformations, intrauterine adhesions, or infertility attributable solely to uterine factors. (4) Incomplete or unclear blastocyst images affecting AI assessment. (5) Other circumstances judged unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210028, China

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Shanshan Wang

CONTACT

+86-13814549922wss_19860820@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 22, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)