Fertilo: Exploring a New Approach IVF and Egg Freezing

Gameto is on a mission to study ways to improve the IVF and egg freezing process by reducing the burden on women and families.

Fertilo Has Been Designed to Enable Rapid Egg Maturation Outside the Body

Fertilo is an investigational cell-based technology aimed at reducing the number of hormonal injections needed for IVF and egg freezing.

Fertilo is designed to support egg maturation outside the body (ex vivo), with the goal of reducing the duration of ovarian stimulation and simplifying the fertility treatment experience. The Fertilo approach involves minimal hormonal stimulation, followed by the retrieval of immature eggs, which are then cultured with engineered ovarian support cells to support maturation in the laboratory (in vitro).

The process of maturing eggs outside the body, known as in vitro maturation (IVM), is not new. In 2021, the American Society for Reproductive Medicine (ASRM) recognized IVM as a nonexperimental procedure, building on decades of clinical research and experience. Fertilo is being investigated as a cell-based approach to IVM, with the goal of improving egg maturation outcomes. Its safety and efficacy are currently being evaluated in the U.S. Phase 3 FIRST trial.

How is Fertilo designed to work?

1 Shortened Hormonal Stimulation

Fertilo is designed to require just 1 to 3 days of hormonal stimulation to prepare your immature eggs for collection. Fewer hormones may lead to fewer side effects, less time spent at the clinic, or an easier cycle overall.

2 Immature Egg Retrieval

Following minimal ovarian stimulation, immature eggs are collected through an egg retrieval procedure performed at a fertility clinic.

3 Egg Maturation with Fertilo

Immature eggs are cultured with Fertilo for approximately 24 hours. Fertilo uses engineered ovarian support cells designed to mimic aspects of the ovarian environment and support egg maturation outside the body.

4 Fertilization or Freezing

Following maturation, mature eggs may be fertilized as part of IVF or frozen for potential future use.

Fertilo is designed to offer an alternative to full stimulation for those who need it – or want it.

“I may not respond well to stimulation.”

Maybe you’ve been diagnosed with PCOS. Or perhaps your body just doesn’t respond normally to stimulation.

“I may not actually need full stimulation.”

Maybe your partner is infertile. Perhaps you’re in a same sex partnership. Or maybe you’re just freezing your eggs for the future.

“I am just trying to avoid all the injections.”

Maybe you need fertility treatment but are anxious about the injections. Or perhaps you just want to try something different.

See how Fertilo could help you along your fertility journey.

Patient-Reported Outcomes From Fertilo Clinical Research

Clinical research involving Fertilo has evaluated patient-reported symptoms and treatment experiences associated with its use as part of a minimal ovarian stimulation approach. The findings provide preliminary information about the treatment experience in the studied population.

In a study conducted across the United States and Spain, participants who underwent the Fertilo protocol reported:

No Breast Swelling

86%

No Pelvic / Abdominal Pain

76%

Regular Menstrual Cycle Month Post Retrieval

86%

No Bleeding / Fever Post Retrieval

98%

No Nausea / Vomiting

96%

No Severe Pain

92%

Among study participants who underwent both a Fertilo and conventional cycle, 92% of patients would repeat the Fertilo cycle, while only 77% would repeat the conventional cycle

Study participants reported an 80% reduction in overall symptoms among patients who have undergone both cycle types

A significant difference was observed in the severe pain levels experienced by participants following the conventional and minimal stimulation cycles, with participants reporting 38% and 8%, respectively

Please note that prior study results may not be reflective of the safety and effectiveness of Fertilo

Source: Donor side effects experienced under minimal controlled ovarian stimulation with in vitro maturation vs. conventional controlled ovarian stimulation for in vitro fertilization treatment

Where is Fertilo available?

Fertilo’s regulatory status and availability vary by country. Explore international availability to learn more about where Fertilo may be accessible outside the United States.

In the United States, Fertilo is an investigational biologic being evaluated for safety and efficacy in the Phase 3 FIRST clinical trial. Fertilo is not FDA-approved.