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

NCT05671601 | Unknown FDA Device

• 1 other identifier: wangshanshan820
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reproductive Medicine

Outcome Measures

Primary Outcomes (1)

• implantation rate

  the probability of successful implantation of the embryo into the uterus

  2022-2023

Study Arms (2)

TLI+AI Assessment Group

Diagnostic Test: Automatic picture recognition

Morphological Assessment Group

Diagnostic Test: Manual Assessment Group

Interventions

Automatic picture recognition DIAGNOSTIC_TEST

A machine that processes photographs automatically taken

TLI+AI Assessment Group

Manual Assessment Group DIAGNOSTIC_TEST

Manual recognition of pictures

Morphological Assessment Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients are under 40 years old and need artificial intervention to have children

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 4, 2023
• Study Start: December 30, 2022
• Primary Completion: December 15, 2023
• Study Completion: June 15, 2024
• Last Updated: January 4, 2023

Record last verified: 2022-11