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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2025-01-31

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial, 1:1 allocation in treatment and control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Morphology

The embryo selection will be based on standard of care traditional morphology only.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Hera Score

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes