Fertilo for In Vitro Maturation

(FIRST Trial)

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

Trial Summary

What is the purpose of this 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. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm. * Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours. * Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.

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.

What data supports the effectiveness of the treatment Fertilo for in vitro maturation?

In vitro maturation (IVM) has been successfully used for patients with polycystic ovarian syndrome, resulting in pregnancies and live births. Although the overall efficiency of IVM is still low compared to conventional methods, it offers potential advantages like lower costs and greater safety. ^{1 2 3 4 5}

Is Fertilo for In Vitro Maturation generally safe for humans?

Research on in vitro maturation (IVM) and related assisted reproductive technologies (ART) like IVF and ICSI suggests they are generally safe, but some studies have noted potential risks such as birth defects and imprinting disorders in offspring. More research is needed to fully understand these risks. ^{6 7 8 9 10}

How does the treatment Fertilo for in vitro maturation differ from other treatments?

Fertilo is unique because it involves maturing immature eggs in the lab before fertilization, which reduces the need for hormonal stimulation and lowers the risk of ovarian hyperstimulation compared to conventional IVF. This approach is particularly beneficial for women with polycystic ovary syndrome and those at high risk for ovarian hyperstimulation. ^{3 4 5 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

In-vitro maturation of human oocytes from regularly menstruating women may be successful without follicle stimulating hormone priming. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Lessons learned from introducing an in-vitro maturation programme into clinical practice. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Oocyte maturation in vitro. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Recombinant LH is equally effective as recombinant hCG in promoting oocyte maturation in a clinical in-vitro maturation programme: a randomized study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

State of the art in in-vitro oocyte maturation. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

A comprehensive assessment of outcomes in pregnancies conceived by in vitro fertilization/intracytoplasmic sperm injection. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

In Vitro Fertilization and Adverse Pregnancy Outcomes in the Elective Single Embryo Transfer Era. [2023]

8. Australia pubmed.ncbi.nlm.nih.gov

Assisted reproductive technologies and birth defects. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Transferability and inter-laboratory variability assessment of the in vitro bovine oocyte fertilization test. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Obstetric outcomes and congenital abnormalities after in vitro maturation, in vitro fertilization, and intracytoplasmic sperm injection. [2009]

11. Japan pubmed.ncbi.nlm.nih.gov

The fertilization ability and developmental competence of bovine oocytes grown in vitro. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

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