Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percentage of Mature Eggs
研究概览
简要总结
The purpose of this prospective single-center study is to evaluate the laboratory outcome after random start ovarian stimulation in oocyte donors. The study will be performed in egg-donors but this type of treatment has the potential to be implemented in general infertility population.
详细描述
The study group will start ovarian stimulation randomly in different moments throughout the menstrual cycle.
Randomization will take place on day 2-3 of the menstrual cycle, according to a list of random allocation of treatments and egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase starting at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11.
Egg-donors will receive urinary follicle stimulating hormone (FSH) 150-225 IU/d in gonadotropin-releasing hormone (GnRH) antagonist protocol with cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation and a GnRH agonist trigger with triptorelin 0,2 mg to induce the final follicular maturation. Transvaginal ultrasound and serum analysis (estradiol, progesterone, LH and FSH) will be included for cycle monitoring.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women
- •18-35 years old
- •FSH levels < 10 IU/liter
- •Antral follicle count (AFC) > 10
- •Regular cycles
- •Body Mass Index (BMI) < 28
- •Signed informed consent
排除标准
- •Polycystic ovary syndrome (PCOS) patients
- •Allergy to gonadotrophins
- •Concomitant participation in other trial
研究组 & 干预措施
Random start ovarian stimulation
Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. They will receive urinary follicle stimulating hormone (FSH) 150-225 International units / daily (IU/d) and five days later the gonadotropin-releasing hormone (GnRH) antagonist: cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.
Interventions:
- Random start ovarian stimulation
- Gonadotrophins: Urinary FSH 150-225 IU/d
- GnRH antagonists: Cetrorelix 0,25 mg/d
- GnRH agonist for triggering: Triptorelin 0,2 mg single dose
干预措施: Random start ovarian stimulation (Other)
Random start ovarian stimulation
Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. They will receive urinary follicle stimulating hormone (FSH) 150-225 International units / daily (IU/d) and five days later the gonadotropin-releasing hormone (GnRH) antagonist: cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.
Interventions:
- Random start ovarian stimulation
- Gonadotrophins: Urinary FSH 150-225 IU/d
- GnRH antagonists: Cetrorelix 0,25 mg/d
- GnRH agonist for triggering: Triptorelin 0,2 mg single dose
干预措施: Gonadotrophins (Drug)
Random start ovarian stimulation
Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. They will receive urinary follicle stimulating hormone (FSH) 150-225 International units / daily (IU/d) and five days later the gonadotropin-releasing hormone (GnRH) antagonist: cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.
Interventions:
- Random start ovarian stimulation
- Gonadotrophins: Urinary FSH 150-225 IU/d
- GnRH antagonists: Cetrorelix 0,25 mg/d
- GnRH agonist for triggering: Triptorelin 0,2 mg single dose
干预措施: GnRH antagonist (Drug)
Random start ovarian stimulation
Egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. They will receive urinary follicle stimulating hormone (FSH) 150-225 International units / daily (IU/d) and five days later the gonadotropin-releasing hormone (GnRH) antagonist: cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later.
Interventions:
- Random start ovarian stimulation
- Gonadotrophins: Urinary FSH 150-225 IU/d
- GnRH antagonists: Cetrorelix 0,25 mg/d
- GnRH agonist for triggering: Triptorelin 0,2 mg single dose
干预措施: GnRH agonist (Drug)
结局指标
主要结局
Percentage of Mature Eggs
时间窗: Up to 24 hours from the oocyte collection
When collected, eggs retain numerous cells (granulosa or cumulus cells) surrounding the oocyte; this structure is termed as the cumulus oocyte complex (COC). Few hours later (2-4 hs), the oocyte is denuded from these cumulus cells, allowing for a clearer observation of the maturity status (presence or absence of a metaphase II) of the oocyte. The percentage of mature eggs represents the proportion resulting from dividing the total number of COCs collected by the number of metaphase II oocytes and multiplied by 100.
次要结局
- Fertilization Rate(24 hours after day of oocyte collection)
研究者
Juan Carlos Castillo
Md. PHd.
Instituto Bernabeu