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New treatment option for In Vitro Maturation of Oocytes
Official title Fertilo In Vitro Research Study and Trial
ClinicalTrials.gov ID: NCT06858111
What this study is testing
What is Fertilo?
Fertilo is an investigational medicine, being studied as a potential treatment for in vitro maturation of oocytes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
- Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clovis, California, United States
- Encino, California, United States
- Clearwater, Florida, United States
- Pembroke Pines, Florida, United States
- Rockville, Maryland, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Raleigh, North Carolina, United States
- Bedford, Texas, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Webster, Texas, United States
- Pleasant Grove, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clovis, California, United States; Encino, California, United States; Clearwater, Florida, United States; Pembroke Pines, Florida, United States; Rockville, Maryland, United States; New York, New York, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.