An Interventional Study to Assess the Efficacy and Safety of Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of oocytes retrieved on the day of Ovum Pick-Up
研究概览
简要总结
This study aims to record Efficacy, Safety and tolerability of Gonapure® prescribed for female subjects with infertility Undergoing IVF/ICSI
详细描述
Gonapure® is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin and contains no luteinizing hormone (LH) activity.
FSH stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Gonapure® is the primary hormone responsible for follicular recruitment and development. In order to affect final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of FSH, when monitoring of the patient indicates that sufficient follicular development has occurred. There is inter-patient variability in response to FSH administration.
The dosage and schedule of treatment for female infertility must be determined according to the needs of each patient; it is usual to monitor response by studying the patient's serum oestrogen level and/or by ultrasonic visualization of follicles.
Treatment should be started within the first 7 days of the menstrual cycle. Treatment is usually begun with 75 to 450 International units daily by intramuscular injection for 7 to 10 days; followed by individual adjustments according to the patient's follicular response i.e. until an adequate, but not excessive, response is achieved.
The investigator will decide the starting dose according to the standard clinical practice (and within the approved label).
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
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged between 18 and 38 years.
- •Female subjects with body mass index (BMI) ≥ 18 and ≤ 40 kilogram per square meter (kg/m^2)
- •Female subjects with basal FSH less than 10 IU/L and PRL serum values within the normal range in the early follicular phase.
- •Female subjects having both ovaries.
- •Female subjects with normal uterine cavity, which in the investigator's opinion is compatible with pregnancy.
- •Female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy.
- •Female subjects who are willing and able to comply with the protocol for the duration of the trial
- •Female subjects who have given written informed consent, prior to any trial-related procedure, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.
排除标准
- •Female subjects with any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug.
- •Female subjects with uterine myoma requiring treatment.
- •Female subjects with any contraindication of being pregnant and/or carrying a pregnancy to term.
- •Female subjects with history of tumors of the hypothalamus and pituitary gland.
- •Female subjects with history of ovarian, uterine or mammary cancer.
- •Female subjects with history of hypersensitivity to the active substance follitropin alpha, FSH, or to any of the excipients of Gonapure ®.
- •Female subjects with untreated hydrosalpinx diagnosed by U/S.
- •Female subjects with abnormal gynecological bleeding of unknown etiology.
- •Female subjects with any medical condition which, in the opinion of the investigator, would prevent an effective response, such as primary ovarian failure, or malformations of the reproductive organs incompatible with pregnancy.
研究组 & 干预措施
Treatment
Follitropin Alfa (Gonapure)
干预措施: Follitropin Alfa (Drug)
结局指标
主要结局
Number of oocytes retrieved on the day of Ovum Pick-Up
时间窗: 50 days after baseline visit (EOS)
Quality of Oocytes Retrieved per participant
时间窗: 50 days after baseline visit (EOS)
It is graded on a good-fair-poor scale: * Good * Clear cytoplasm/normal shape * Single distinct polar body * Clear/thin zona pellucida * Fair * Slightly grainy cytoplasm/misshapen * Fragmented/abnormal polar body * Slightly pigmented/amorphous zona * Cytoplasmic bodies * PV (vitelline platelets) debris * Poor * Dark/grainy cytoplasm/misshapen * \>1 polar body structure * Pigmented/thickened zona * Vacuoles * PV (vitelline platelets) debris * Good Quality embryos per participant. Those embryos that have reached the most advanced developmental stage and have the least cellular fragmentation (Grades "A" and/or "B") will be considered Good Quality embryos and will be selected for transfer. * Number of transferred embryos per participant. * Percentage of Participants with Clinical Pregnancy. Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan.
Number of Mature Oocytes (MII) Retrieved Per Participant
时间窗: 50 days after baseline visit (EOS)
Metaphase II (MII): The oocyte is in the second phase of meiosis and is mature. Oocytes at this stage of maturity are ready for fertilization. Mean number of Mature oocytes (MII) retrieved on the day of ovum pick up (OPU) will be calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
次要结局
- Total & Mean Gonapure ® Daily Dose(14 days)
- Eventual AE/SAEs related to the administration of Gonapure®(50 days after baseline visit (EOS))
- Number of follicles ≥ 18 mm on day of administration of hCG(50 days after baseline visit (EOS))
- Number of Participants with Multiple Pregnancies(50 days after baseline visit (EOS))
- Number of Participants with Ovarian Hyperstimulation Syndrome(50 days after baseline visit (EOS))