InfertilityLOTUSNCT05483985
Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer
A study testing Hera Score in people with Infertility, run by Alife Health at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Hera Score
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Jul 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Ovation Fertility
Austin, Texas, 78731
IVF Florida Reproductive Associates
Margate, Florida, 33063
CCRM
Menlo Park, California, 94025
Aspire Fertility
San Antonio, Texas, 78258
Reproductive Science Center
San Ramon, California, 94583
Reproductive Care Center
Sandy City, Utah, 84092
Center for Reproductive Medicine
Winter Park, Florida, 32789
About this study
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
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Hera Score
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hera ScoreDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hera Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.
Measured: up to 8 weeks
Secondary outcomes (2)
Incidence of disagreement
Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist.
Measured: week 1
User Experience
Assessment of Hera System usability as reported by the embryologist using a user questionnaire.
Measured: through study completion at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start11 Jul 2022
- Primary completion19 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial, 1:1 allocation in treatment and control group.
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alife Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483985
- Sponsor's protocol ID
- CIP-01
- Acronym
- LOTUS
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05483985
- Acronym / sponsor ID
- LOTUS / CIP-01
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Alife HealthIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial, 1:1 allocation in treatment and control group.
| Arm | Type | Receives |
|---|---|---|
| Traditional Morphology | No intervention | –The embryo selection will be based on standard of care traditional morphology only. |
| Device: Hera System | Experimental | Device: Hera ScoreFor 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. |
Who may qualify
- Ages
- 21 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- >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)
Key exclusion criteria (8 listed)
- Gestational carriers
- Use of re-inseminated eggs
- Use of donor eggs
- History of cancer
- Fertilization using surgically removed sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hera ScoreThe 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 | Device: Hera System |
Primary outcome
Primary Endpoint
Time frame: up to 8 weeks
The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks.
2 secondary outcomes
Incidence of disagreement
Time frame: week 1
User Experience
Time frame: through study completion at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hera Score in people with Infertility, run by Alife Health at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.