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

Reproductive Medicine Clinical Trial

Official title:

Application of Deep Learning Automation Based on Time-lapse Imaging to Jointly Assess Embryo Development to Improve Pregnancy Outcome of Single Blastocyst Transfer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05671601
• Other study ID #: wangshanshan820
• Status: Not yet recruiting
• Start date: December 30, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: November 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reproductive Medicine

Intervention

Diagnostic Test:
• Automatic picture recognition
A machine that processes photographs automatically taken
• Manual Assessment Group
Manual recognition of pictures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate	the probability of successful implantation of the embryo into the uterus	2022-2023