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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility
• Intervention / Treatment: Device: Hera Score

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.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • CCRM
    • San Ramon, California, United States, 94583
      • Reproductive Science Center
  • Florida
    • Margate, Florida, United States, 33063
      • IVF Florida Reproductive Associates
    • Winter Park, Florida, United States, 32789
      • Center for Reproductive Medicine
  • Texas
    • Austin, Texas, United States, 78731
      • Ovation Fertility
    • San Antonio, Texas, United States, 78258
      • Aspire Fertility
  • Utah
    • Sandy, Utah, United States, 84092
      • Reproductive Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. >21 and < 43 years of age
2. Women undergoing in vitro fertilization treatment using their own eggs
3. At least 8 eggs retrieved
4. Fertilization using only ejaculated sperm including donor sperm (fresh or frozen)
5. Single embryo transfer (SET)
6. Willing to comply with study protocol and procedures and be able to speak English
7. Willing to provide written informed consent

Exclusion Criteria:

1. Gestational carriers
2. Use of re-inseminated eggs
3. Use of donor eggs
4. History of cancer
5. Fertilization using surgically removed sperm
6. Transfer of multiple (more than one) embryos at once
7. Participants undergoing IVF with intent to bank embryos (i.e. no intention of embryo transfer for at least 6 months following egg retrieval)
8. Concurrent participation in another clinical study that might interfere with the study results in either study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Traditional Morphology; The embryo selection will be based on standard of care traditional morphology only.
Experimental: Device: Hera System; For the Hera, the embryologist will use the consider both the standard morphology grade and the Hera System score on embryos that were already deemed suitable for transfer or freeze based on the standard morphology assessment to determine the most suitable embryo for transfer.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of disagreement	Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist.	week 1
User Experience	Assessment of Hera System usability as reported by the embryologist using a user questionnaire.	through study completion at 8 weeks

Collaborators and Investigators

• Sponsor: Alife Health

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: CIP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes