Hera System for Infertility

(LOTUS Trial)

Not currently recruiting at 7 trial locations

Overseen By Vaishali Suraj, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Alife Health

Disqualifiers: Cancer, Donor eggs, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Hera System might improve pregnancy rates for women undergoing in vitro fertilization (IVF). Researchers aim to determine if using the Hera System alongside standard methods helps select the best embryo for transfer. In this study, some embryos will be chosen using only traditional methods, while others will be evaluated using both the Hera System's score and the traditional method. Women undergoing IVF with their own eggs and planning to transfer only one embryo at a time are ideal candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance IVF success rates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Hera System is safe for use in embryo selection?

Research shows that the Hera System is designed to help select the best embryos for transfer during fertility treatments. However, specific safety information isn't available from the sources provided. This trial doesn't follow a typical clinical trial phase, suggesting that few past safety studies may exist.

The Hera System uses a computer program to evaluate embryos and adheres to general safety rules, such as ensuring system functionality and maintaining data privacy, according to some guidelines mentioned in the sources. This indicates that, despite being a new tool, it prioritizes safety and privacy.

Overall, while exact safety data is lacking, the emphasis on safe and effective systems offers some reassurance. It's advisable to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hera System for infertility because it offers a new way to select the best embryos for transfer. Traditional methods rely solely on examining embryo morphology, but the Hera System adds a unique layer by incorporating a specialized score that evaluates embryos deemed suitable based on standard assessments. This approach could enhance the accuracy of embryo selection, potentially leading to higher success rates in assisted reproductive technologies. By blending standard morphology with the Hera System score, embryologists may be able to make more informed decisions, increasing the chances of successful pregnancies.

What evidence suggests that the Hera System is effective for infertility?

Research has shown that the Hera System might improve embryo selection in fertility treatments. In this trial, one group of participants will have embryo selection based solely on traditional morphology. Another group will use the Hera System as an additional tool, considering both the standard morphology grade and the Hera System score. A study tested the Hera System and found it could help prioritize embryos more effectively. This suggests the system might assist embryologists in selecting the best embryos for transfer, potentially increasing pregnancy rates. However, detailed comparisons with traditional methods are not yet available. By combining traditional methods with the Hera System, there might be a better chance of achieving a successful pregnancy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for women aged 21-43 undergoing in vitro fertilization with their own eggs, who have retrieved at least 8 eggs and are planning a single embryo transfer. They must be willing to follow the study's rules and speak English. Those using donor sperm are eligible, but not those using surgically removed sperm or donor eggs, intending to bank embryos, having cancer history, or aiming for gender selection.

Inclusion Criteria

Women undergoing in vitro fertilization treatment using their own eggs

At least 8 eggs retrieved

Single embryo transfer (SET)

Exclusion Criteria

Gestational carriers

Fertilization using surgically removed sperm

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Embryos are evaluated using the Hera System alongside traditional morphology grading to determine suitability for transfer

8 weeks

Regular visits as per embryology lab schedule

Follow-up

Participants are monitored for clinical pregnancy, defined as a fetal heartbeat at 6-8 weeks

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hera Score

Trial Overview The trial is testing the Hera System as an additional method alongside traditional morphological grading of embryos suitable for transfer in IVF treatments. It aims to compare pregnancy rates (confirmed by fetal heartbeat) when using this system versus standard criteria used by embryologists alone.

How Is the Trial Designed?

Group I: Device: Hera System Experimental Treatment 1 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 Morphology Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Alife Health

Lead Sponsor

Trials

1

Recruited

440+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10219399/

Review of Endometrial Receptivity Array: A Personalized ... The study concluded that there was no significant difference in live birth rate between patients who underwent ERA testing prior to FET (56.5%) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024002785

Effectiveness of the Addressing Reproductive Coercion in ... The ICC for the primary outcome was 0.008 at the three-month follow-up and 0.005 at the twelve-month follow-up, demonstrating decreasing facility-level ...

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1251699/full

Does endometrial receptivity array improve reproductive ... The results revealed that the implantation rate (55.6% vs. 65.0%) and the pregnancy rate (58.3% vs.70.6%) did not show significant differences ...

4. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-alife-hera-system-as-an-adjunctive-tool-for-the-prioritization-of-embryos-deemed-s

Evaluation of the Alife Hera System as an Adjunctive Tool for ... To evaluate the performance and utilization of the Hera System as an adjunctive embryo grading and prioritization tool in an embryology lab ...

5. withpower.com withpower.com/trial/phase-infertility-5-2022-0b27b

Hera System for Infertility (LOTUS Trial) This trial aims to see if using the Hera System can improve pregnancy rates in patients undergoing fertility treatments. The system helps embryologists ...

6. fertstert.org fertstert.org/news-do/polygenic-revolution-and-future-embryo-testing

The Polygenic Revolution and The Future of Embryo Testing Polygenic risk score for embryo selection: Not ready for prime time. Human Reproduction 2022. 37(10): 2229–2236. [5] Moore S, Davidson I ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10643792/

The HERA (Hyper-response Risk Assessment) Delphi ... The HERA (Hyper-response Risk Assessment) Delphi consensus for the management of hyper-responders in in vitro fertilization

8. fertstert.org fertstert.org/article/S0015-0282(23)00523-X/pdf

regulation of adaptive algorithms in reproduction The blueprint outlines five core principles: safe and effective sys- tems; algorithmic discrimination pro- tections; data privacy; notice and explanation; and ...

9. withpower.com withpower.com/clinical-trials/for-infertility

Top Infertility Clinical Trials | Power This trial aims to see if using the Hera System can improve pregnancy rates in patients undergoing fertility treatments. The system helps embryologists choose ...

10. herabiolabs.com herabiolabs.com/storage/2023/08/Hera-Capabilites-and-Technology.pdf

Hera Services & Technology Developed using Hera Biolabs' advanced gene editing technology, is a SCID rat on the Sprague-Dawley background that harbors a double knockout for the. Rag2 and ...