Fertilo In Vitro Research Study and Trial

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures. [Срок оценки: 12 weeks gestation]

Вторичные конечные точки (8)

• Metaphase II (MII) Formation [Срок оценки: 30 hours post-oocyte retrieval]
• Fertilization Rate [Срок оценки: 16-18 hours post-ICSI]
• Embryo cleavage rate [Срок оценки: Day 3 post-ICSI]
• High quality blastocyst formation rate. [Срок оценки: Day 5, 6, and 7 post-ICSI]
• High quality vitrified blastocyst rate. [Срок оценки: Day 5, 6, and 7 post-ICSI]
• Cumulative biochemical pregnancy. [Срок оценки: 10 to 14 days following FET]
• Cumulative clinical pregnancy. [Срок оценки: 4-6 weeks gestation]
• Cumulative live birth. [Срок оценки: Greater than 24 weeks gestation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 13 центров

• 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
• … и ещё 5 центров

Идентификаторы

NCT: NCT06858111 · GAM-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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