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

NCT05483985 | Active Not Recruiting FDA Device

• 1 other identifier: CIP-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.

  up to 8 weeks

Secondary Outcomes (2)

• Incidence of disagreement

  week 1

• User Experience

  through study completion at 8 weeks

Study Arms (2)

Traditional Morphology

NO INTERVENTION

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

Device: Hera System

EXPERIMENTAL

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

Interventions

Hera Score 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.

Device: Hera System

Eligibility Criteria

• Age: 21 Years - 43 Years
• Gender Eligibility Details: All women undergoing IVF
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \>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

You may not qualify if:

• 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)
• Concurrent participation in another clinical study that might interfere with the study results in either study

Sponsors & Collaborators

• Alife Health: lead

Study Sites (7)

CCRM

Menlo Park, California, 94025, United States

Location

Reproductive Science Center

San Ramon, California, 94583, United States

Location

IVF Florida Reproductive Associates

Margate, Florida, 33063, United States

Location

Center for Reproductive Medicine

Winter Park, Florida, 32789, United States

Location

Ovation Fertility

Austin, Texas, 78731, United States

Location

Aspire Fertility

San Antonio, Texas, 78258, United States

Location

Reproductive Care Center

Sandy City, Utah, 84092, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: June 13, 2022
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (7)