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Recruiting NCT06858111

Fertilo In Vitro Research Study and Trial

Phase III Interventional In Vitro Maturation of Oocytes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fertilo, Medicult IVM.
Who it may be relevant to
Registry conditions: In Vitro Maturation of Oocytes. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)

Overview

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.

Interventions

  • Biological Fertilo
    Fertilo is an engineered line of ovarian support cells that aid egg maturation.
  • Device Medicult IVM
    MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.

Primary outcome measures

  • Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures. [Time frame: 12 weeks gestation]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion 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 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.
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 13 centers
  • Women's Specialty & Fertility Center — Clovis
  • HRC Fertility — Encino
  • Florida Fertility Institute — Clearwater
  • IVF Florida — Pembroke Pines
  • Shady Grove Fertility — Rockville
  • Columbia University Fertility Center — New York
  • Reach Fertility — Charlotte
  • Conceptions Fertility — Raleigh
  • … and 5 more centers

Identifiers

NCT: NCT06858111 · GAM-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗