What side effects are associated with this type of intervention?

Common treatments for infertility, particularly those involving advanced embryo selection technologies like the Hera System, include ovarian stimulation, in vitro fertilization (IVF), and embryo transfer. The side effects of these treatments can vary. Ovarian stimulation with gonadotropins may cause ovarian hyperstimulation syndrome (OHSS), which can lead to swollen, painful ovaries, and in severe cases, fluid accumulation in the abdomen and chest. GnRH agonists, used to control hormone levels, can cause menopausal symptoms such as hot flashes, mood swings, and headaches. Progesterone supplementation, often used to support the luteal phase, can lead to bloating, breast tenderness, and mood changes. Additionally, the IVF procedure itself carries risks such as multiple pregnancies, which can increase the likelihood of complications for both the mother and the babies, and the potential for procedural complications like infection or bleeding.

What prior FDA approvals exist?

The FDA has approved several treatments for infertility, particularly focusing on controlled ovarian hyperstimulation and embryo selection. Commonly used drugs include gonadotropins such as recombinant follicle-stimulating hormone (FSH) and human menopausal gonadotropin (hMG), which are used to stimulate the ovaries to produce multiple follicles. Gonadotropin-releasing hormone (GnRH) agonists and antagonists are also approved to prevent premature ovulation during IVF cycles. Additionally, clomiphene citrate and letrozole are oral medications approved for ovulation induction. These treatments aim to increase the number of available embryos for selection, similar to the goals of advanced embryo selection technologies like the Hera System.

What other types of research exist?

Promising alternatives to the Hera System for embryo selection in 2024 include: 1) Advanced morphokinetic algorithms that predict embryo implantation potential based on time-lapse imaging, 2) Preimplantation Genetic Testing (PGT) for aneuploidy screening to select chromosomally normal embryos, and 3) Artificial Intelligence (AI)-driven platforms that integrate multiple data points (e.g., genetic, morphokinetic, and clinical data) to enhance embryo selection accuracy.

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Hera System for Infertility (LOTUS Trial)

N/A

Waitlist Available

Research Sponsored by Alife Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using the Hera System can improve pregnancy rates in patients undergoing fertility treatments. The system helps embryologists choose the best embryos by providing extra information, potentially increasing the chances of pregnancy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves assessment rather than medication or invasive procedures, there aren't direct side effects from the Hera Score itself. However, general risks associated with IVF procedures still apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint

Secondary study objectives

Incidence of disagreement

User Experience

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for infertility, particularly those involving assisted reproductive technologies (ART) like in vitro fertilization (IVF), work by stimulating the ovaries to produce multiple eggs, retrieving these eggs, fertilizing them with sperm in a laboratory, and then transferring the resulting embryos into the uterus. Advanced embryo selection technologies, such as the Hera System, enhance this process by using morphological grading and potentially other criteria to prioritize the best-quality embryos for transfer. This matters for infertility patients as it increases the chances of successful implantation and pregnancy, reduces the risk of miscarriage, and may decrease the number of cycles needed to achieve a live birth, thereby improving overall treatment outcomes and reducing emotional and financial burdens.

Therapeutic options for premature ovarian insufficiency: an updated review.Fresh insight into premature ovarian insufficiency.Poor responders in assisted reproduction cycles.