NCT07236476进行中（未招募）2 期
A Multicentre, Open-label, Dose-finding, Phase 2 Study to Investigate the Efficacy, and Safety of Different Doses of LY01021 in Controlled Ovarian Hyperstimulation(COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Inhibition rate of premature LH surge
研究概览
简要总结
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent of subjects and their spouses;
- •Married infertile female subjects aged 20 to 40 years (40 years exclusive) with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
- •Weight 45Kg ~ 80Kg (both inclusive), and body mass index (BMI) 19.0 ~ 28.0kg/m2;
- •Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to screening;
- •Anticipated normal ovarian response;
- •Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle；
- •Normal cervical cytology results (TCT) or with limited clinically significance within 6 months prior to screening; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV).
排除标准
- •Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy；
- •Previous IVF/ ICSI failure due to sperm/fertilization problems/low fertilization rate(<30%) and no improvement in related medical condition;
- •Subjects with more than 2 times of spontaneous abortion;
- •Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);
- •Subjects with low ovarian function;
- •Any pregnancy that occurred within 3 months prior to screening;
- •Unexplained abnormal vaginal bleeding within 6 months prior to screening;
- •Subjects with serious infection, severe trauma or major surgical procedure within 6 months prior to screening.
- •ALT and AST levels at the screening visit or the start of ovarian stimulation were more than twice the upper limit of normal;
- •Positive serum β-hCG test at the screening visit or the start day of ovarian stimulation;
- •Past medical history or gynecological ultrasound indicates clinically significant conditions;
- •Any disease or symptom that can affect systemic function or may affect the absorption, accumulation, metabolism, or excretion of the test drug (e.g., chronic intestinal diseases, Crohn's disease, ulcerative colitis).
- •Major systemic diseases, endocrine or metabolic abnormalities;
- •Thromboembolic diseases or a history of thromboembolic diseases;
- •The subject or her spouse or both of them carry a chromosomal abnormality, or suffer from a known monogenic hereditary disease or a severe disease with genetic susceptibility requiring pre-implantation genetic testing (excluding chromosomal polymorphisms);
- •Malignant tumor or history of malignant tumor (except basal cell or squamous cell skin cancer, papillary thyroid carcinoma, in situ cancer );
- •Use of fertility regulators within 1 month prior to ovarian stimulation, such as clomiphene citrate, letrozole, gonadotropins (Gn), hormonal drugs (including oral contraceptives, estrogens, progestogens, etc.) bromocriptine, etc..
- •Subjects who have used strong inducers/inhibitors of cytochrome P450 3A4 (CYP3A4), strong inducers/inhibitors of P-glycoprotein (P-gp), or gastric acid secretion inhibitors within 2 weeks or 5 half-lives (whichever is longer) before the first administration of LY01021;
- •Any other reasons deemed by the researcher as unsuitable for participation in this study.
研究组 & 干预措施
LY01021
Experimental
Treatment group 40mg: oral LY01021; 40mg QD p.o.; Treatment group 30mg: oral LY01021; 30mg QD p.o.; Treatment group 20mg: oral LY01021; 20mg QD p.o.;
干预措施: LY01021 (Drug)
结局指标
主要结局
Inhibition rate of premature LH surge
时间窗: From Day 5 to the hCG injection 1 day
次要结局
- Number of oocyte retrieved per COH cycle(On oocyte retrieval 1 day)
- 2PN rate.(16-18 hours (h) after fertilization)
- High quality embryo rate.(3 days after fertilization)
- Chemical pregnancy rate.(13-15 days after transplantation)
- Clinical pregnancy rate.(30-37 days after transplantation)
- Persistent pregnancy rate.(70-84 days after transplantation)
- Adverse events.(Through study completion, an average of 3 months)
研究者
研究点 (1)
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