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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Device: Hera Score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >21 and < 43 years of age Women undergoing in vitro fertilization treatment using their own eggs At least 8 eggs retrieved Fertilization using only ejaculated sperm including donor sperm (fresh or frozen) Single embryo transfer (SET) Willing to comply with study protocol and procedures and be able to speak English Willing to provide written informed consent Exclusion Criteria: Gestational carriers Use of re-inseminated eggs Use of donor eggs History of cancer Fertilization using surgically removed sperm Transfer of multiple (more than one) embryos at once Participants undergoing IVF with intent to bank embryos (i.e. no intention of embryo transfer for at least 6 months following egg retrieval) Participants undergoing IVF with intent of gender sex selection Concurrent participation in another clinical study that might interfere with the study results in either study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial, 1:1 allocation in treatment and control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional Morphology<br>The embryo selection will be based on standard of care traditional morphology only. | |
| Experimental: Device: Hera System<br>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<br>* 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.<br>|

What is the study measuring?
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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 |