In Vitro Maturation of OocytesPhase 3FIRSTNCT06858111
Fertilo In Vitro Research Study and Trial
A Phase 3 study testing Fertilo and Medicult IVM in people with In Vitro Maturation of Oocytes, run by Gameto, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Maturation of Oocytes
- What is being tested?
- Fertilo and Medicult IVM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 16 sitesUnited States
- Study dates
- 17 Apr 2025to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
- Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
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- Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit.
- Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit.
- 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.
- No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma.
- Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation.
- 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.
Who cannot join
- 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.
- Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
- 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.
- Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Aspire Fertility Dallas
Addison, Texas, 75001
Alexis Denson, 214-414-3806, Research@inceptionllc.com
Christine Mansfield, MD
- Recruiting
Aspire Fertility Austin
Austin, Texas, 78705
Laurel Schultz, 512-479-7979, Research@inceptionllc.com
Angela Kelley, MD
- Recruiting
Care Fertility
Bedford, Texas, 76022
Michelle Evans, 817-540-7070 ext. 1033, michellee@embryo.net
Charlene Nwajei, charlenen@embryo.net
- Recruiting
Reach Fertility
Charlotte, North Carolina, 28207
Stephanie Graham, MS, 704-343-4455, Stephanie.Graham@northcarolinafertility.com
Jack Crain, MD
- Recruiting
Florida Fertility Institute
Clearwater, Florida, 33759
Gayle Cameron, 727-724-9730, gaylec@xxresearch.com
Mark Sanchez, MD
- Recruiting
Women's Specialty & Fertility Center
Clovis, California, 93611
Casey Study Coordinator, 559-299-7700, cstorm@santehealth.net
Howard Synn, MD
- Recruiting
Dallas Fort Worth Fertility Associates
Dallas, Texas, 75231
Jenny Patel, 214-363-5965, thirdparty@dallasfertility.com
Samuel Chantilis, MD
- Recruiting
HRC Fertility
Encino, California, 91436
Shanise Ashiem, 818-788-7288, clinicaltrialsENC@havingbabies.com
Robert Boostanfar, MD
- Recruiting
Columbia University Fertility Center
New York, New York, 10019
Stephanie Morgan, 212-314-8837, sm3415@cumc.columbia.edu
Eric Forman, MD
- Recruiting
IVF Florida
Pembroke Pines, Florida, 33026
Karina Stroker, 954-247-6200 ext. 62518, karina.stroker@usfertility.com
Luis Hoyos, MD
- Recruiting
Utah Fertility Center
Pleasant Grove, Utah, 84062
Coral Halterman, RN, 801-785-5100 ext. 7036, coral.halterman@utahfertility.com
Shawn Gurtcheff, MD
- Recruiting
Conceptions Fertility
Raleigh, North Carolina, 27607
Sofia Sequeira, 919-782-5911, ccresearch@carolinaconceptions.com
John Park, MD
- Recruiting
Shady Grove Fertility
Rockville, Maryland, 20850
Joshua McKeeby, 301-545-1423, sgfclinicalresearchteam@sgfertility.com
Kate Devine, MD
- Recruiting
Pozitivf Fertility San Antonio
San Antonio, Texas, 78249
Jose Acevedo, 210-404-2229 ext. 3046, jose.acevedo@pozitivf.com
Francisco Arredondo, MD
- Recruiting
Aspire Fertility San Antonio
San Antonio, Texas, 78528
Laurel Anderson, 210-337-8453, Research@inceptionllc.com
Jennifer Knudtson, MD
- Recruiting
Shady Grove Houston
Webster, Texas, 77598
Cara Barrier, RN, 832-342-9129, cara.barrier@sgfertility.com
Maryanne Fisher, RN, 281-557-3084, maryanne.fisher@sgfertility.com
About this study
Official title: Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)
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.
- Conditions
- In Vitro Maturation of Oocytes
- Being tested
- Fertilo, Medicult IVM
- Keywords
- IVF, IVM, In Vitro Fertilization, Fertilo, Gameto, infertility, fertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertiloBiological
Fertilo is an engineered line of ovarian support cells that aid egg maturation.
Medicult IVMDevice
MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.
| Study group | Role | What they receive |
|---|---|---|
| Fertilo | Experimental | 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. Receives: Biological: Fertilo |
| Medicult IVM® | Active comparator | 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. Receives: Device: Medicult IVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks gestation
Secondary outcomes (8)
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.
Measured: 30 hours post-oocyte retrieval
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.
Measured: 16-18 hours post-ICSI
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.
Measured: Day 3 post-ICSI
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.
Measured: Day 5, 6, and 7 post-ICSI
High quality vitrified blastocyst rate.
High quality vitrified blastocyst rate is assessed at day 5, 6 and 7 post-ICSI. Embryos deemed high quality, as measured by a Gardner score of 3CC of greater, that have been vitrified, a method of rapid cryopreservation for future embryo transfer, will be designated as high quality vitrified blastocysts. The high quality vitrified blastocyst rate is measured as a Subject's total number of high quality blastocysts that are vitrified divided by their total number of COCs. The high quality vitrified blastocyst rate is multiplied by 100 and expressed as a percentage.
Measured: Day 5, 6, and 7 post-ICSI
Cumulative biochemical pregnancy.
Cumulative biochemical pregnancy from cycles initiated within 6 months post randomization. Biochemical pregnancy is assessed at 10 to 14 days following FET. Cumulative biochemical pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with BHCG value greater than 5 mIU/mL on two separate tests are considered as achieving biochemical pregnancy. Biochemical pregnancy is recorded as either a Yes or No for each of the Subject's transfer cycles. Subjects without a biochemical pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., a clinical pregnancy, ongoing pregnancy, or live birth). Cumulative biochemical pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves a biochemical pregnancy, or a No otherwise.
Measured: 10 to 14 days following FET
Cumulative clinical pregnancy.
Cumulative clinical pregnancy from cycles initiated within 6 months post randomization is assessed at 4-6 weeks gestation. Cumulative clinical pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a gestational sac visualized with TVU are considered as having achieved a clinical pregnancy. Clinical pregnancy is recorded as either a Yes or No for each of the Subject's transfer cycles. Subjects without a clinical pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., an ongoing pregnancy or live birth). Cumulative clinical pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves a clinical pregnancy, or a No otherwise.
Measured: 4-6 weeks gestation
Cumulative live birth.
Cumulative live birth from cycles initiated within 6 months post-randomization. Live birth is confirmed at >24 weeks gestation by the presence of signs of life such as breathing, heartbeat, pulsation of the umbilical cord, or definitive movement of voluntary muscles. Cumulative live birth is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with at least one neonate meeting the definition of live birth are considered as having achieved a live birth. Live birth is recorded as either a Yes or No for each of the Subject's transfer cycles. Subjects without a live birth assessment are considered as a No. Cumulative live birth is derived as either a Yes, if at least one of the first two embryo transfers achieves a live birth, or a No otherwise.
Measured: Greater than 24 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start17 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro Maturation of OocytesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gameto, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858111
- Sponsor's protocol ID
- GAM-01
- Acronym
- FIRST
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)
- ClinicalTrials.gov ID
- NCT06858111
- Acronym / sponsor ID
- FIRST / GAM-01
- Conditions
- In Vitro Maturation of Oocytes
- Keywords
- IVF, IVM, In Vitro Fertilization, Fertilo, Gameto, infertility, fertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Gameto, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fertilo | Experimental | Biological: FertiloImmature 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. |
| Medicult IVM® | Active comparator | Device: Medicult IVMImmature 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 may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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).
- No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
Key exclusion criteria (7 listed)
- 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.
- Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FertiloFertilo is an engineered line of ovarian support cells that aid egg maturation. | Biological | Fertilo |
| Medicult IVMMediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes. | Device | Medicult IVM® |
Primary outcome
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
Time frame: 12 weeks gestation
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.
8 secondary outcomes
Metaphase II (MII) Formation
Time frame: 30 hours post-oocyte retrieval
Fertilization Rate
Time frame: 16-18 hours post-ICSI
Embryo cleavage rate
Time frame: Day 3 post-ICSI
High quality blastocyst formation rate.
Time frame: Day 5, 6, and 7 post-ICSI
High quality vitrified blastocyst rate.
Time frame: Day 5, 6, and 7 post-ICSI
Cumulative biochemical pregnancy.
Time frame: 10 to 14 days following FET
Cumulative clinical pregnancy.
Time frame: 4-6 weeks gestation
Cumulative live birth.
Time frame: Greater than 24 weeks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fertilo and Medicult IVM in people with In Vitro Maturation of Oocytes, run by Gameto, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (512-535-1164, clinicaltrials@gametogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures. (time frame: 12 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.