No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 35
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Other
Participants needed
500 (estimated)
Sponsor
Gameto, Inc. · Industry
Who this trial is looking for
This trial is looking for women aged 18-35 who are facing difficulties getting pregnant. Participants will undergo a procedure using Fertilo to mature eggs and will be monitored for ongoing pregnancies.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18-35
I have a BMI between 21 and 40
I can provide written consent
I have been trying to get pregnant for at least 12 months
I will use embryos for transfer within 2 months of their storage
I have an adequate hormone level (AMH ≥ 3 ng/mL)
I have a normal uterine cavity
I have no significant issues with my ovaries
You may not be able to join if
I have had more than 2 pregnancies without a live birth
My prolactin levels are higher than 30 ng/ml
I require surgery to retrieve sperm
I have a medical condition that may affect pregnancy
I am using genetic testing for embryos during this study
I plan to use donated eggs or embryos during the study
I am participating in another clinical trial
I have endometriosis that is severe
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Status
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 medi…
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.
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