NCT05483985

Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer

Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer: A Randomized Controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Alife Health · Industry
• Sex: Female
• Age: 21 Years – 43 Years
• Healthy volunteers: Accepted

Summary

To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.

Detailed description

To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone. To evaluate the performance and utilization of the Hera System as an adjunctive embryo grading and prioritization tool in an embryology lab setting with trained embryologists.

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	Hera Score	The device uses patient metadata (patient age, day of image capture) and a software algorithm to analyze features of the blastocyst morphology to provide adjunctive information that may predict further development of the embryo to clinical pregnancy after embryo transfer.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2022-08-02
• Last updated: 2024-04-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study