A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART (IVF/ICSI).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Estradiol (E2) Levels on r-hCG Day
研究概览
简要总结
This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).
详细描述
Polycystic ovarian syndrome population is an androgenic syndrome characterized by a wide spectrum of clinical manifestations such as obesity, hirsutism, insulin resistance, diabetes and presence of specific ultrasonic features.
Cetrotide®, cetrorelix acetate, is an antagonist of luteinizing-hormone-releasing hormone (LHRH). Cetrotide® is registered in 70 countries (including France) for the prevention of premature ovulation in subjects undergoing a controlled ovarian stimulation, followed by oocyte pick-up and ARTs. Ovitrelle®, active ingredient human chorionic-gonadotropin alfa, is administered to trigger final follicular maturation and luteinization after stimulation of follicular growth.
OBJECTIVES
Primary objective:
- To compare the hormonal level of plasmatic estradiol on the releasing day (day of r-hCG administration) induced by Cetrotide® 0.25 mg/day started on Day 1 (Group A: Day 1) or on Day 7 (Group B: Day 7) of the menstrual cycle (Day 0 (S0) or Day 6 (S6) of stimulation) in PCO subjects undergoing IVF/ICSI procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus
- •Female subjects suitable for IVF/ICSI, undergoing first or second attempt
- •18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least from Visit 0 (V0)
- •Normal FSH value (less than 10 international unit per liter [IU/L]) on Day 3 of spontaneous cycle within 12 months prior to the trial
- •Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter [ng/mL]) of a spontaneous cycle within 12 months prior to the trial or at least at V0
- •No history of active genito-urinary infection
- •Normal thyroid function (or adequate substitution for at least 3 months)
- •Negative cervical papanicolaou test within the last 12 months prior to study entry
- •No gonadotropins, for at least one month prior to the trial
- •No metformin therapy for at least one month prior to Visit 1 (V1)
- •Subject who is able to participate in the trial and has provided written, informed consent.
排除标准
- •Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
- •Drilling 3 months prior to V0
- •Uterine malformation, diethylstilbestrol syndrome, synechia
- •Female subjects with World Health Organization (WHO) Type I or III anovulation
- •Female subjects with hyperprolactinemia
- •Female subjects with more than 2 recurrent miscarriages (early or late, and for any reasons)
- •Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner
- •Abnormal gynecological bleeding of undetermined origin
- •History of major thromboembolic disease
- •Endometriosis (Grade III or IV)
- •Presence or history of malignant tumors and related treatment
- •Known case of tumors of the hypothalamus or pituitary gland
- •Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
- •Known allergic reaction or hypersensitivity to Cetrotide® or Ovitrelle®
- •Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
- •Participation in another clinical trial within 3 months prior to study entry.
研究组 & 干预措施
Day 1 protocol
干预措施: Cetrorelix acetate (Drug)
Day 1 protocol
干预措施: Recombinant Human Choriogonadotropin (r-hCG) (Drug)
Day 1 protocol
干预措施: Recombinant human follicle stimulating hormone (r-hFSH) (Drug)
Day 7 protocol
干预措施: Cetrorelix acetate (Drug)
Day 7 protocol
干预措施: Recombinant Human Choriogonadotropin (r-hCG) (Drug)
Day 7 protocol
干预措施: Recombinant human follicle stimulating hormone (r-hFSH) (Drug)
结局指标
主要结局
Estradiol (E2) Levels on r-hCG Day
时间窗: r-hCG day (end of stimulation cycle [approximately 15 days])
次要结局
- Serum Estradiol (E2) Levels(Day 1)
- Percentage of Participants With Clinical Pregnancy(10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days]))
- Serum Progesterone (P4) Levels(Day 1)
- Anti Mullerian Hormone (AMH) Levels(Day 0)
- Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day(r-hCG day (end of stimulation cycle [approximately 15 days]))
- Number of Embryos(Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]))
- Number of Blastocysts(Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]))
- Number of Transferred Embryos(Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]))
- Implantation Rate(5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to end of study (15 days post last administration of study drug))
- Number and Quality of Oocytes Retrieved(Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]))
- Percentage of Fertilized Oocytes Retrieved(Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}]))
- Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels(Day 1)
- Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)(Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days]))