Fertilo In Vitro Research Study and Trial
ConditionIn Vitro Maturation of Oocytes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorGameto, Inc.
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent.
Premenopausal, Age 18-35.
Body mass index (BMI) 21-40.
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).
Disqualifiers
History of recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
Baseline prolactin levels greater than 30 ng/ml
Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
Trial design
Design model
Parallel
Treatments tested in this trial
Fertilo
Biological/VaccineFertilo is an engineered line of ovarian support cells that aid egg maturation.
Medicult IVM
DeviceMediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: FertiloExperimental treatment 1 intervention
Group B: Medicult IVM®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
Cumulative ongoing pregnancy from cycles initiated within 6 months post-randomization. The primary endpoint of ongoing pregnancy is assessed at 12 weeks gestation or later. Cumulative ongoing pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a detectable fetal heartbeat, considered normal and healthy, are considered as having achieved an ongoing pregnancy. "Normal" will be determined as expected for the gestational age ranging from 110 bpm to 180 bpm and measured via ultrasound. Ongoing pregnancy is recorded as either a Yes or No for normal fetal heart rate present for each of the Subject's transfer cycles. Subjects without an ongoing pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., a live birth). Cumulative ongoing pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves an ongoing pregnancy, or a No otherwise.
Time frame
12 weeks gestationSecondary outcomes
1
Metaphase II (MII) Formation
MII formation rate is assessed at 30 hours post-oocyte retrieval. A Metaphase II (MII) oocyte is defined as an oocyte with a first polar body (PB1). The MII formation rate is measured as a Subject's total number of MII oocytes divided by their total number of COCs. The MII formation rate is multiplied by 100 and expressed as a percentage.
Time frame
30 hours post-oocyte retrieval2
Fertilization Rate
Fertilization rate is assessed at 16-18 hours post-ICSI. Fertilized embryos displaying 2 pronuclei and 2 polar bodies are considered normally fertilized. Fertilized embryos with no pronuclei are considered not fertilized. Fertilized embryos with one pronuclei are held to determine cleavage, as pronuclei visualization timing may mask the second pronucleus. The fertilization rate is measured as a Subject's total number of fertilized embryos divided by their total number of COCs. The fertilization rate is multiplied by 100 and expressed as a percentage.
Time frame
16-18 hours post-ICSI3
Embryo cleavage rate
Embryo cleavage rate is assessed at day 3 post-ICSI. Embryos with 2 or more cells are considered as cleaved. Fertilized embryos displaying a single cell will be considered not cleaved. The cell cleavage rate is measured as a Subject's total number of embryos considered as cleaved divided by their total number of COCs. The cell cleavage rate is multiplied by 100 and expressed as a percentage.
Time frame
Day 3 post-ICSI4
High quality blastocyst formation rate.
High quality blastocyst formation rate is assessed at day 5, 6 and 7 post-ICSI. Embryos that have successfully passed the morula stage, as indicated by cavitation, will be designated as blastocysts and will be graded according to the Gardner Scale. Blastocysts having a Gardner Scale score of 3CC or higher are considered as high quality blastocysts. The high quality blastocyst formation rate is measured as a Subject's total number of high quality blastocysts divided by their total number of COCs. The high quality blastocyst formation rate is multiplied by 100 and expressed as a percentage.
Time frame
Day 5, 6, and 7 post-ICSISponsors and contacts
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Source ClinicalTrials.gov