Fertilo for In Vitro Maturation

(FIRST Trial)

Recruiting at 10 trial locations

Overseen By Clinical Trials

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Gameto, Inc.

Disqualifiers: Recurrent pregnancy loss, High prolactin, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Fertilo surpasses the standard treatment, Medicult IVM, in helping eggs mature in a lab setting. Researchers are comparing the number of successful pregnancies resulting from each treatment. The trial involves two groups: one group uses Fertilo to mature their eggs, while the other uses Medicult IVM. Women who have been trying to conceive for over a year without success and are planning to use IVF might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking fertility treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop taking clomiphene citrate, GnRH agonist, or gonadotropins for at least 1 month before starting ovarian stimulation. The protocol does not specify other medication restrictions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Fertilo has undergone safety testing in several ways. Animal studies, specifically with mice, have found it to be safe. This finding suggests the treatment might also be safe for humans. Fertilo aims to make the process of maturing eggs outside the body safer and more effective, potentially reducing the need for hormonal injections. Avoiding these injections could mean fewer side effects for patients, as they can sometimes cause adverse effects.

For Medicult IVM, no new safety data is available in the sources. However, its use as a standard comparison in the trial suggests that its safety is already well established, with any associated risks likely well-known and monitored.

Overall, Fertilo has shown promising safety results in animal studies, and Medicult IVM is a standard treatment with a known safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fertilo is unique because it offers a novel approach to in vitro maturation by culturing immature cumulus-oocyte complexes (COCs) in a specialized coculture condition. Unlike the standard MediCult IVM® system, which is commonly used, Fertilo aims to enhance the maturation process, potentially improving the quality and viability of the resulting embryos. Researchers are excited about Fertilo because it could lead to more successful fertilization and embryo development, offering hope for improved outcomes in assisted reproductive technologies.

What evidence suggests that this trial's treatments could be effective for in vitro maturation?

Research has shown that Fertilo, which participants in this trial may receive, may help increase pregnancy rates for people using in vitro maturation (IVM). Early results from studies found that Fertilo led to pregnancy rates more than twice as high as traditional IVM methods. Additionally, 70% of eggs matured with Fertilo reached maturity, compared to 52% with other methods. These findings suggest that using Fertilo could improve the chances of successful pregnancies for those undergoing IVM treatments. This trial will compare Fertilo with the standard IVM system, MediCult IVM®, to evaluate its effectiveness. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for premenopausal women aged 18-35, with a BMI of 21-40, who are candidates for IVF. They must have normal ovarian function (AMH ≥ 3 ng/mL), no severe endometriosis or uterine abnormalities, and be able to use oral contraceptives and gonadotropins. Participants should plan to use their embryos within two months after freezing.

Inclusion Criteria

My BMI is between 21 and 40.

I do not have severe endometriosis or cysts related to it.

I am a woman aged 18-35 and have not gone through menopause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants' cumulus oocyte complexes (COCs) are cultured in either Fertilo or Medicult IVM for 30 hours, followed by fertilization and growth to the blastocyst stage

1 week

Follow-up

Participants are monitored for ongoing pregnancy, embryo development, and other outcomes

6 months

Outcome Assessment

Assessment of cumulative ongoing pregnancy, clinical pregnancy, and live birth outcomes

Up to 24 weeks gestation

What Are the Treatments Tested in This Trial?

Interventions

• Fertilo

Trial Overview The study compares Fertilo and Medicult IVM for in vitro maturation of eggs in women undergoing IVF. It measures the number of ongoing pregnancies at 12 weeks by culturing eggs in either Fertilo or Medicult IVM for 30 hours to see which method is more effective.

How Is the Trial Designed?

Group I: Fertilo Experimental Treatment 1 Intervention

Immature cumulus-oocyte complexes (COCs) are oocytes surrounded by cumulus cells that have not yet matured. The COCs are cultured in Fertilo coculture condition then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose.

Group II: Medicult IVM® Active Control 1 Intervention

Immature COCs are cultured in the standard IVM system MediCult IVM® then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose.

Who Is Running the Clinical Trial?

Gameto, Inc.

Lead Sponsor

Trials

1

Recruited

500+

Published Research Related to This Trial

In-vitro maturation (IVM) allows immature oocytes to mature from the germinal vesicle stage to metaphase 2 in about 28-36 hours, showing promise for patients with polycystic ovarian syndrome and normal menstruating women.

Approximately 300 healthy children have been born worldwide from IVM, indicating its potential as a safe alternative to standard ovarian stimulation, although further research is needed to fully understand its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from introducing an in-vitro maturation programme into clinical practice. von Otte, S., Schöpper, B., Diedrich, K., et al.[2019]

In-vitro maturation (IVM) of immature oocytes, especially when combined with hormonal priming, has shown improved maturation rates and embryo quality, leading to pregnancy rates of 30-35% in women with polycystic ovaries or polycystic ovary syndrome.

Over 300 healthy infants have been born from IVM, demonstrating its efficacy as a viable alternative to traditional IVF methods, allowing for successful pregnancies without the need for ovarian stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the art in in-vitro oocyte maturation. Chian, RC., Lim, JH., Tan, SL.[2019]

In vitro maturation (IVM) is a technique that allows immature oocytes to mature without the need for hormonal stimulation, making it a safer option for patients at high risk of ovarian hyperstimulation.

The results from IVM are comparable to standard IVF techniques, and there is currently no evidence of increased risk for fetal malformations, making it a suitable alternative for specific patients, particularly those with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro maturation (IVM) of human oocytes. Strowitzki, T.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06858111

NCT06858111 | Fertilo In Vitro Research Study and Trial The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age.

2. gametogen.com gametogen.com/science/fertilo/

Fertilo Early clinical results show that Fertilo achieved a pregnancy rate more than double that of conventional in vitro maturation (IVM). This study ...

3. firstwordpharma.com firstwordpharma.com/story/5947955

Gameto Announces Landmark Pregnancy Rate for iPSC ... The study found that eggs matured with Fertilo were significantly more likely to develop properly, with a 70% maturation rate compared to 52% ...

4. finance.yahoo.com finance.yahoo.com/news/gameto-announces-landmark-pregnancy-rate-123000741.html

Gameto Announces Landmark Pregnancy Rate for iPSC ... The study found that eggs matured with Fertilo were significantly more likely to develop properly, with a 70% maturation rate compared to 52% ...

5. ctv.veeva.com ctv.veeva.com/study/fertilo-in-vitro-research-study-and-trial

Fertilo In Vitro Research Study and Trial - ClinicalTrials.Veeva The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age.

6. isrctn.com isrctn.com/ISRCTN36032472

Evaluation of the safety of ovarian support cell in vitro ... The objective of this observational study is to evaluate the safety of the ovarian support cell in vitro maturation (OSC-IVM) product application, known as ...

7. prnewswire.com prnewswire.com/news-releases/gameto-unveils-new-data-on-in-vitro-maturation-product-candidate-fertilo-during-four-presentations-at-the-2023-american-society-for-reproductive-medicine-301961653.html

Gameto Unveils New Data on In Vitro Maturation Product ... The study determined that Fertilo has been shown to be safe in a mouse reprotoxicology model. Gameto presented findings of Fertilo's use ...