A Retrospective Study in Chinese Good Prognosis Patients Undergoing ART Treatment to Investigate the Factors Associated With the Pregnancy Outcome of GnRH Antagonist IVF/ICSI Cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 4
- 主要终点
- Total Number of Embryos on Day 3/Blastocysts on Day 5
研究概览
简要总结
This is a multicenter retrospective study in good prognosis Chinese patients. Data will be collected from infertile women who underwent first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than 35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10 milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2), previously underwent no more than 3 IVF/ICSI cycles, and the total dose of Gonadotropin used no more than 2500 IU in current cycle. No intervention(s) will be administered on the subjects. Data required to investigate the factors associated with the pregnancy outcome of GnRH antagonist IVF cycle will be collected from the subjects' medical records into database through electronic data capture system and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women who underwent the first GnRH antagonist IVF/ICSI-ET (Embryo Transfer) cycle with an available ART outcome
- •Used Cetrotide in a fixed or flexible antagonist protocol
- •Age not more than 35 years old
- •Baseline serum Follicle-stimulating hormone (FSH) level not more than 10 milliinternational unit per milliliter (mIU/ml)
- •Body mass index (BMI) not more than 30 kilogram per meter square (kg/m^2)
- •Normal uterine cavity
排除标准
- •Previously underwent 3 or more IVF/ICSI cycles
- •The total dose of Gonadotropin used was more than 2500 IU in current cycle
- •Administration of daily 0.125 milligram (mg) Cetrotide
- •Received an agonist trigger
- •Use of clomiphene citrate or letrozole during cycles
- •Presence of endometriosis Grade 3 to 4, confirmed or suspected
- •Presence of uni-or-bilateral hydrosalpinx
- •Known history of recurrent miscarriages
研究组 & 干预措施
Cetrotide
This study will retrospectively collect the data from the subjects who had been treated with 0.25 milligram (mg) of Cetrotide injection daily in a fixed or flexible antagonist protocol with an available assisted reproductive technology (ART) outcome.
干预措施: No Intervention (Drug)
结局指标
主要结局
Total Number of Embryos on Day 3/Blastocysts on Day 5
时间窗: Day 3 and Day 5
Age
时间窗: Baseline
Duration of Infertility
时间窗: Baseline
Number of Embryos/Blastocysts Transferred on Day 3 or Day 5
时间窗: Day 3, Day 5
Number of Good Quality Embryos/Blastocysts Transferred
时间窗: up to 5 months
Type of Infertility
时间窗: Baseline
Clinical Pregnancy Rate
时间窗: 5 months
Number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, and embryo transfer cycles. Initiated cycle: an assisted reproductive technology (ART) cycle in which the woman receives specific medication for ovarian stimulation, or monitoring in the case of natural cycles, with the intention to treat, irrespective of whether or not follicular aspiration is attempted. Aspiration cycle Initiated ART cycle in which one or more follicles are punctured and aspirated irrespective of whether or not oocytes are retrieved. Embryo transfer cycle: an ART cycle in which one or more embryos are transferred into the uterus or fallopian tube.
Live Birth Rate
时间窗: 5 months
Number of live births expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When delivery rates are given, the denominator (initiated, aspirated, or embryo transfer cycles) will be specified
Serum Luteinizing Hormone (LH) Level on the Day of Starting Cetrotide
时间窗: on the day of starting Cetrotide (up to 5 months)
Serum Estradiol (E2) Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
时间窗: on the day of hCG triggering (up to 5 months)
Endometrial Thickness on the Day of Human Chorionic Gonadotropin (hCG) Triggering
时间窗: on the day of hCG triggering (up to 5 months)
Early Miscarriage Rate
时间窗: 5 months
(Number of Early miscarriages/Number of clinical pregnancies)\*100
Serum Estradiol (E2) Level on the Day of Starting Cetrotide
时间窗: on the day of starting Cetrotide (up to 5 months)
Serum Luteinizing Hormone (LH), Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
时间窗: 5 months
Number of Follicles With Size 14 milimeter (mm) or More on the Day of Human Chorionic Gonadotropin (hCG) Triggering
时间窗: on the day of hCG triggering (up to 5 months)
Serum Luteinizing Hormone (LH) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
时间窗: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (\>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Number of Mature Metaphase II Oocytes Obtained
时间窗: 5 months
Fertilization Rate
时间窗: 5 months
Total Dose of Gonadotropin
时间窗: 5 months
Duration of Gonadotropin Administration
时间窗: 5 months
Number of Cryopreservation Embryos/Blastocysts on Day 3 or Day 5
时间窗: Day 3, Day 5
Smoking Status
时间窗: Baseline
Cause of Infertility
时间窗: Baseline
Endometrial Thickness on the Day of Observed Premature Luteinizing Hormone (LH) Rise
时间窗: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (\>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Serum Progesterone Level on the Day of Observed Premature Progesterone Rise
时间窗: on the day of observed premature progesterone rise (up to 5 months)
Premature progesterone rise: A rise in serum progesterone levels above 1.5 nanogram/milliliter (ng/ml) towards the end of the follicular phase up to and including the day of the trigger
Ongoing Pregnancy Rate
时间窗: 5 months
Ongoing pregnancy rate per embryo transfer cycles = (Number of Ongoing pregnancy/Number of embryo transfer cycles)\*100 and ongoing pregnancy rate per initiated cycles = (Number of Ongoing pregnancy/Number of initiated cycles) \*100
Brand of Gonadotropin
时间窗: 5 months
Cetrotide Start Day
时间窗: up to 5 months
Leading Follicle Size on the Day of Starting Cetrotide
时间窗: on the day of starting Cetrotide (up to 5 months)
Number of Oocytes Obtained
时间窗: 5 months
Body Mass Index (BMI)
时间窗: Baseline
Implantation Rate
时间窗: 5 months
Implantation rate = (The number of gestational sacs observed divided by the number of embryos transferred)\*100
Incidence and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
时间窗: 5 months
Cycle Cancelled Rate
时间窗: 5 months
Cycle cancelled rate = (Number of subjects with terminated in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) treatment/Number of initiated cycles)\*100
Type of Gonadoptropin
时间窗: 5 months
Progesterone Level on the Day of Human Chorionic Gonadotropin (hCG) Triggering
时间窗: on the day of hCG triggering (up to 5 months)
Serum Estradiol (E2) Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
时间窗: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (\>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Serum Progesterone Level on the Day of Observed Premature Luteinizing Hormone (LH) Rise
时间窗: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (\>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
Number of Follicles With Size 14 mm or More on the Day of Observed Premature Luteinizing Hormone (LH) Rise
时间窗: on the day of observed premature LH rise (up to 5 months)
Subjects will be characterized as having a premature LH rise if any measured LH value during follicular recruitment will more than (\>) 10 International Units Per Litre (IU/L) up to and including the day of the trigger
次要结局
未报告次要终点