Application of Deep Learning to Jointly Assess Embryo Development to Improve Pregnancy Outcome of Embryo Transfer

Not yet recruiting

• Conditions: Reproductive Medicine
• Interventions: Diagnostic Test: Automatic picture recognition; Diagnostic Test: Manual Assessment Group

• Registration Number: NCT05671601
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

Aim of this research is to apply the deep learning automation based on Time-lapse imaging to jointly assess embryo development，so that it can ensure the consistency of embryo evaluation and improve the accuracy of evaluation.

Detailed Description

This study is an observational prospective study after a retrospective analysis. It is a single-center study without randomization or blindness. In the early stage, 1000 patients are collected from three periods of embryo culture through Time-lapse to establish an automated joint evaluation system for the whole process of embryo development. At the later stage, the patients are divided into two groups: Time-Lapse imaging (TLI) +Artificial Intelligence(AI) assessment group and morphological assessment group. 100 patients with Day 5 single blastocyst transplantation are carried out to follow up the pregnancy outcome.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-26
• Last Update Submitted: 2022-12-26
• Study Start: 2022-12-30
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-12-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• (1) Age < 40 years old; (2) Routine IVF cycles; (3) Period number ≤ 2; (4) The number of ova collected is 5-15; (5) BMI: 18-25 kg/m 2, follicle stimulating hormone(FSH) ≤ 12 IU/L on the third day; (6) Patients with more than 3 high-quality embryos on Day3 and performed single blastocyst transplantation on day 5. (7) Patient without endometrial factors.

Exclusion Criteria

• (1) Preimplantation Genetic Testing(PGT) is needed due to male infertility, ovulation cycle and chromosome abnormalities; (2) there are systemic diseases of clinical significance; (3) Pictures of blastocysts are not formed or available; (4) Incomplete or unclear image collection in prokaryotic, mitotic and blastocyst phases affected AI evaluation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TLI+AI Assessment Group	Automatic picture recognition	-
Morphological Assessment Group	Manual Assessment Group	-

Primary Outcome Measures

Name	Time	Method
implantation rate	2022-2023	the probability of successful implantation of the embryo into the uterus