Clinical trial NCT06858111: Fertilo In Vitro Research Study and Trial
Official title: Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: In Vitro Maturation of Oocytes
Keywords: IVF
IVM
In Vitro Fertilization
Fertilo
Gameto
infertility
fertility
Lead sponsor: Gameto, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Premenopausal, Age 18-35.
3. Body mass index (BMI) 21-40.
4. Candidate for IVF according to the ASRM definition (infertile for ≥12 months, require the use of donor sperm, or the inability to achieve a successful pregnancy based on a patient's medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors).
5. No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
6. Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
7. Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit.
8. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit.
9. Having adequate visualization of both ovaries, without evidence of significant abnormality/pathology or major cyst documented by transvaginal ultrasound within 3 months of screening or assessed during screening period.
10. No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma.
11. Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation.
12. Have a male partner with semen analysis within the past 12 months prior to randomization considered adequate to proceed with intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If this criterion is not met, the subject can only be entered if donor sperm will be used.

Exclusion Criteria:

1. History of recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
2. Baseline prolactin levels greater than 30 ng/ml
3. Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
4. Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
5. Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
6. Use of donated oocytes, embryos or blastocysts for this treatment cycle while participating in the study or use of oocytes, embryos, or blastocysts from a previous treatment cycle.
7. Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.

Primary outcomes:
measure: Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
timeFrame: 12 weeks gestation
Secondary outcomes:
measure: Metaphase II (MII) Formation
timeFrame: 30 hours post-oocyte retrieval
measure: Fertilization Rate
timeFrame: 16-18 hours post-ICSI
measure: Embryo cleavage rate
timeFrame: Day 3 post-ICSI
measure: High quality blastocyst formation rate.
timeFrame: Day 5, 6, and 7 post-ICSI
measure: High quality vitrified blastocyst rate.
timeFrame: Day 5, 6, and 7 post-ICSI
measure: Cumulative biochemical pregnancy.
timeFrame: 10 to 14 days following FET
measure: Cumulative clinical pregnancy.
timeFrame: 4-6 weeks gestation
measure: Cumulative live birth.
timeFrame: Greater than 24 weeks gestation
Other outcomes:
Locations:
city: Corona
country: United States
facility: Reproductive Fertility Center
state: California
city: Charlotte
country: United States
facility: Reach Fertility
state: North Carolina
Study officials:
References: