NCT01863680已完成3 期
Open-label, Single-arm, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of COL-1620 8% Vaginal Progesterone Gel for Luteal Phase Support in In-vitro Fertilization and Embryo Transfer (IVF/ET) Cycles in Japanese Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate Per Embryo Transfer
研究概览
简要总结
The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology [JSOG] 2009 registry data: 24.3 percent [%]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Japanese race
- •Woman with a history of infertility and in whom In-vitro fertilization and embryo transfer (IVF/ET) is indicated
- •The controlled ovarian stimulation (COS) therapy is gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) in combination with a follicle-stimulating hormone (FSH) containing preparation
- •Healthy premenopausal woman aged between 20 and 45 years (inclusive) and wishing to conceive
- •Body mass index (BMI) of 17.0 to 25.0 kilogram per square meter (kg/m^2) (inclusive)
- •A negative pregnancy test (urinary beta-human chorionic gonadotropin [hCG]) prior to starting COS
- •Normal cervical smear result (Papanicolaou [PAP] test: Negative for Intraepithelial Lesion or Malignancy [NILM] or [Atypical Squamous Cells of Undetermined Significance {ASC-US} and Human Papillomavirus {HPV} negative]) within 12 months prior to the date of informed consent. If not available, a cervical smear and HPV test will be performed as part of Screening
- •No clinically significant abnormal findings in the screening hematology, biochemistry and urinalysis parameters
- •Full comprehension of the study and voluntary written informed consent obtained in writing prior to any trial-related activities
排除标准
- •History of recurrent pregnancy loss (defined as 3 or more previous spontaneous abortions)
- •History of 3 or more consecutive cancelled or failed (no clinical pregnancy) IVF/ET cycles
- •Abnormal hemorrhage of the reproductive tract of undetermined origin
- •Any contraindication to being pregnant and/or carrying a pregnancy to term (for example, malformations of sexual organs or fibroid tumors of the uterus incompatible with pregnancy)
- •Uterine myoma requiring treatment
- •Extra-uterine pregnancy within the last 3 months prior to the date of informed consent
- •History or presence of intracranial tumor (for example, hypothalamic or pituitary tumor)
- •Presence of or suspected gonadotropin- or estrogen-dependent malignancy (for example, ovarian, uterine or mammary carcinoma)
- •Ovarian enlargement or cyst of unknown etiology
- •Breast-feeding or lactation
- •History of severe Ovarian Hyperstimulation Syndrome (OHSS) (Classification of OHSS Severity, as per Japan Reproductive/Endocrine Working Group)
- •Known Human Immunodeficiency Virus (HIV)-positive status, or a history of or current active infection with Hepatitis B or C
- •Known allergy or hypersensitivity to progesterone preparations or gonadotropin preparations and/or their excipients, or any contraindication to receive medication for controlled ovarian stimulation (for example, gonadotropin, GnRH analogues, combined oral contraceptive pill, as appropriate)
- •History of or suspected alcohol or substance abuse within 5 years prior to the date of informed consent
- •Clinically significant systemic disease (for example, insulin-dependent diabetes, epilepsy, severe migraine, acute porphyria, hepatic, renal or cardiovascular disease, severe corticosteroid-dependent asthma)
- •Active thrombophlebitis, thromboembolic disorder or cerebral apoplexy, or a history of such conditions
- •Other significant disease that in the Investigator's or Sub-Investigator's opinion would exclude the subject from the trial
- •Participation in another clinical trial within 3 months prior to the date of informed consent or simultaneous participation in another clinical trial
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
COL-1620
Experimental
干预措施: COL-1620 (Drug)
COL-1620
Experimental
干预措施: Gonadotropin-releasing hormone (GnRH) analogue (Drug)
COL-1620
Experimental
干预措施: Follicle-stimulating hormone (FSH) (Drug)
COL-1620
Experimental
干预措施: Human Chorionic Gonadotropin (hCG) (Drug)
结局指标
主要结局
Clinical Pregnancy Rate Per Embryo Transfer
时间窗: Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])
Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.
次要结局
- Biochemical Pregnancy Rate Per Embryo Transfer(Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU]))
- Serum Progesterone Level(Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3))
研究者
研究点 (1)
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