Back to resultsEvaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer (LOTUS)
Primary Purpose
Infertility
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hera Score
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Reproductive Science CenterRecruiting
- Ovation FertilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Traditional Morphology
Device: Hera System
Arm Description
The embryo selection will be based on standard of care traditional morphology only.
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.
Outcomes
Primary Outcome Measures
Primary Endpoint
The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.
Secondary Outcome Measures
Incidence of disagreement
Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist.
User Experience
Assessment of Hera System usability as reported by the embryologist using a user questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05483985
Brief Title
Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alife Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial, 1:1 allocation in treatment and control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional Morphology
Arm Type
No Intervention
Arm Description
The embryo selection will be based on standard of care traditional morphology only.
Arm Title
Device: Hera System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hera Score
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Incidence of disagreement
Description
Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist.
Time Frame
week 1
Title
User Experience
Description
Assessment of Hera System usability as reported by the embryologist using a user questionnaire.
Time Frame
through study completion at 8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All women undergoing IVF
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vaishali Suraj, MS
Phone
4088913321
Email
vsuraj@alifehealth.com
Facility Information:
Facility Name
Reproductive Science Center
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barash Oleksii, PhD
Facility Name
Ovation Fertility
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew VerMilyea, PhD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer
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