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Hera Score for Infertility (LOTUS Trial)

Research Sponsored by Alife Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women undergoing in vitro fertilization treatment using their own eggs
Single embryo transfer (SET)
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights

LOTUS Trial Summary

This trial is testing whether the Hera System, used with traditional morphological grading, can improve the clinical pregnancy rate for embryos already deemed suitable for transfer.

LOTUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
You are going through fertility treatment using your own eggs.
Only one embryo will be transferred during the procedure.

LOTUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint
Secondary outcome measures
Incidence of disagreement
User Experience

LOTUS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Device: Hera SystemExperimental Treatment1 Intervention
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 II: Traditional MorphologyActive Control1 Intervention
The embryo selection will be based on standard of care traditional morphology only.

Find a Location

Who is running the clinical trial?

Alife HealthLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity for individuals in this research endeavor?

"Affirmative, the clinicaltrials.gov website states that this medical experiment is in search of participants. It was initially posted on June 13th 2022 and more recently amended on July 29th 2022. This trial requires 230 patients to be enrolled across 2 distinct locations."

Answered by AI

Does the trial allow for participants aged under twenty years?

"The eligibility requirements for this experiment outline that participants must be between the ages of 21 to 43, inclusive."

Answered by AI

Is this study currently accepting participants?

"According to clinicaltrials.gov, enrolment is still open for this medical trial which was initially advertised in June of 2022 and last reviewed at the end of July."

Answered by AI

Am I eligible to partake in this clinical trial?

"This fertility research is seeking 230 participants aged between 21 and 43, who possess the qualifications to comply with the study protocol. Furthermore, these individuals must speak English fluently and be undergoing in vitro fertilization (IVF) treatment using their own eggs; a minimum of 8 eggs need to be retrieved for this procedure. Fertilization should only use ejaculated sperm, including donor sperm either fresh or frozen., followed by single embryo transfer (SET). To participate in this trial, each candidate must provide written informed consent."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Ovation Fertility
~81 spots leftby Apr 2025