Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
研究概览
简要总结
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 其他
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
Fertilo
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.
干预措施: Fertilo (Biological)
Medicult IVM®
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.
干预措施: Medicult IVM (Device)
结局指标
主要结局
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
时间窗: 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.
次要结局
- Metaphase II (MII) Formation(30 hours post-oocyte retrieval)
- Fertilization Rate(16-18 hours post-ICSI)
- Embryo cleavage rate(Day 3 post-ICSI)
- High quality blastocyst formation rate.(Day 5, 6, and 7 post-ICSI)
- High quality vitrified blastocyst rate.(Day 5, 6, and 7 post-ICSI)
- Cumulative biochemical pregnancy.(10 to 14 days following FET)
- Cumulative clinical pregnancy.(4-6 weeks gestation)
- Cumulative live birth.(Greater than 24 weeks gestation)
研究者
研究点 (15)
标识符
- NCT 编号
- NCT06858111
- 其他研究编号
- GAM-01
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (7个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).