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

Infertility Clinical Trial

— LOTUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05483985
• Other study ID #: CIP-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Alife Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
United States	Ovation Fertility	Austin	Texas
United States	IVF Florida Reproductive Associates	Margate	Florida
United States	CCRM	Menlo Park	California
United States	Aspire Fertility	San Antonio	Texas
United States	Reproductive Science Center	San Ramon	California
United States	Reproductive Care Center	Sandy	Utah
United States	Center for Reproductive Medicine	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alife Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.	up to 8 weeks
Secondary	Incidence of disagreement	Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist.	week 1
Secondary	User Experience	Assessment of Hera System usability as reported by the embryologist using a user questionnaire.	through study completion at 8 weeks