A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 201
- 主要终点
- T5 defined as the time that embryo needs to reach a 5-cell stage.
研究概览
简要总结
The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.
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 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women <38 years old
- •Weight <60 kg
- •Own oocytes
- •Patients have to provide signed informed consent
排除标准
- •Oocyte donors
- •Vitrified oocytes
- •Severe male factor (<1 million spz/ml)
- •Weight >60 kg
研究组 & 干预措施
Corifollitropin alfa
Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.
干预措施: Corifollitropin alfa (Drug)
recombinant FSH
Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.
干预措施: Corifollitropin alfa (Drug)
HP- hMG
Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .
干预措施: Corifollitropin alfa (Drug)
结局指标
主要结局
T5 defined as the time that embryo needs to reach a 5-cell stage.
时间窗: Baseline
次要结局
- Fertilization rate(A month)
- Length of stimulation (days)(a month)
- Total dose of gonadotropins (IU)(A month)
- Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation(A month)
- Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation(A month)
- Levels of progesterone (ng/ml)(A month)
- Number of embryos transferred and cryopreserved(A month)
- Pregnancy rate(A month)
- Implantation rate(A monthe)
- Miscarriage rate(A month)
- Cancellation rate per cycle initiated(A month)
- Ovarian hyperstimulation syndrome rate(A month)
- Timings of cellular divisions(A month)
研究者
Juan A Garcia-Velasco
PhD MD
IVI Madrid