NCT00844311已完成4 期
Supplementation With hCG During Controlled Ovarian Stimulation With Recombinant FSH for in Vitro Fertilisation. A Randomized Controlled Clinical Study. Clinical, Embryological, Endocrine and Genetic Aspects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total number of top-quality embryos at day 3
研究概览
简要总结
The purpose of this trial is to study whether addition of different doses of human chorionic gonadotropins during controlled ovarian stimulation for patients undergoing IVF will improve the number of top-quality embryos.
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
- 25 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with indication for COS and IVF;
- •Age between 25-37 years;
- •BMI >18 and < 30 kg/m2;
- •A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
- •Two ovaries;
- •Tubal or unexplained infertility, including endometriosis stage I/II;
- •A uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) documented by transvaginal ultrasound at the screening;
- •Male partner with sperm quality compatible with fertilization via IVF procedure or previous clinical pregnancy;
- •Early follicular phase serum FSH levels of 1-12 IU/l;
- •Early follicular phase total antral follicle (2-10mm) count ≥ 6;
- •Confirmation of down-regulation before randomisation by transvaginal ultrasound;
- •Willing and able to sign informed consent.
排除标准
- •History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
- •History of severe ovarian hyperstimulation syndrome (OHSS);
- •Presence of unilateral or bilateral hydrosalpinx at ultrasound;
- •More than three previously COS cycles;
- •Previous poor response on an IVF-cycle, defined as >20 days of gonadotrophin stimulation, cancellation due to limited follicular response or less than four follicles of ³15 mm diameter;
- •Previous IVF cycle with unsuccessful fertilization, defined as fertilisation of £20% of the retrieved oocytes;
- •History of recurrent miscarriage;
- •FSH>12IU/L or LH>12UI/L (early follicular phase);
- •Contraindications for the use of gonadotropins or GnRH analogues;
- •Recent history of current epilepsy, HIV infection, diabetes or cardiovascular gastrointestinal, hepatic, renal or pulmonary disease;
- •Pregnancy, lactation or contraindication to pregnancy;
- •Current past (last 12 months) abuse of alcohol or drugs;
- •History of chemotherapy (except for gestational conditions) of radiotherapy;
- •Undiagnosed vaginal bleeding;
- •Tumours of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy;
- •Abnormal karyotyping of the patient (if karyotyping is performed);
- •Hypersensitivity to any trial product.
研究组 & 干预措施
hCG low dose
Experimental
150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1
干预措施: rFSH (Drug)
hCG low dose
Experimental
150 iu/day of rFSH + 50 iu/day of hCG from stimulation day 1
干预措施: human chorionic gonadotropin (Drug)
hCG medium dose
Experimental
150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1
干预措施: rFSH (Drug)
Control arm
Active Comparator
150 iu/day of rFSH alone
干预措施: rFSH (Drug)
hCG medium dose
Experimental
150 iu/day of rFSH + 100 iu/day of hCG from stimulation day 1
干预措施: human chorionic gonadotropin (Drug)
hCG high dose
Experimental
150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1
干预措施: rFSH (Drug)
hCG high dose
Experimental
150 iu/day of rFSH + 150 iu/day of hCG from stimulation day 1
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
Total number of top-quality embryos at day 3
次要结局
- Implantation rate; Dose of rFSH needed; Serum levels of endocrine parameters; Ongoing pregnancy; Follicular fluid levels of endocrine parameters and cytokines; Expressions of gene families in granulosa cells and the cumulus complex.
研究者
研究点 (1)
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