Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle
研究概览
简要总结
To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.
详细描述
This is a prospective cross-over study. Investigators want to study the effect of different dosages of recombinant FSH in the same patient on the expression of the FSH- and LH-receptors in the granulosa cells and on the endocrine milieu in the blood and the follicular fluid. An improved understanding of the mechanism leading to progesterone elevation might initiate a change in the ovarian stimulation approach, thereby not only preventing progesterone elevation and its negative consequences on ART (Assisted Reproductive Technology) outcome, but also improving individualization of the ovarian stimulation treatment according to the patients' characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years
- •BMI of 18-32 kg/m2
- •Regular menstrual cycles with a length of 24-35 days
- •Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019)
排除标准
- •Occurrence of ovarian hyperstimulation syndrome (OHSS)
- •Occurrence of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) in previous ovarian stimulation treatment (20)
- •Polycystic ovary syndrome (PCOS) (21)
研究组 & 干预措施
Daily 150 IU recFSH
Follitropin beta injection 150 IU daily
干预措施: Follitropin beta injection 150 IU (Drug)
Daily 300 IU recFSH
Follitropin beta injection 300 IU daily
干预措施: Follitropin beta injection 300 IU (Drug)
结局指标
主要结局
Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle
时间窗: 5 days
Number of FSHR- and LHR of the GC, obtained from tone follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm, punctured during the ovarian stimulation cycle
时间窗: 1 day
Number of FSHR- and LHR of the GC, obtained from two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation, punctured during the ovarian stimulation cycle
时间窗: 1 day
Number of FSHR- and LHR of the GC, obtained from the follicular fluid of follicles aspirated during OPU
时间窗: 1 day
次要结局
- Level of FSH hormone in the blood, on the day of OPU(1 day)
- Level of P4 hormone in the blood, on the day of OPU(1 day)
- Level of E2 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of P4 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of FSH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of LH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of E2 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm(1 day)
- Level of P4 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm(1 day)
- Level of FSH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm(1 day)
- Level of LH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm(1 day)
- Level of P4 hormone in the blood, on the morning of the day of final oocyte maturation(1 day)
- Level of E2 hormone in the blood, on the morning of the day of final oocyte maturation(1 day)
- Level of LH hormone in the blood, on the morning of the day of final oocyte maturation(1 day)
- Level of E2 hormone in the blood, on the day of OPU(1 day)
- Level of FSH hormone in the blood, on the morning of the day of final oocyte maturation(1 day)
- Level of P4 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of FSH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of LH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of LH hormone in the blood, on the day of OPU(1 day)
- Level of E2 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist(5 days)
- Level of E2 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm(1 day)
- Level of P4 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm(1 day)
- Level of FSH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm(1 day)
- Level of LH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm(1 day)
- Level of E2 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation(1 day)
- Level of P4 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation(1 day)
- Level of FSH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation(1 day)
- Level of LH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation(1 day)
- Level of E2 hormone in the follicular fluid of follicles aspirated during OPU(1 day)
- Level of P4 hormone in the follicular fluid of follicles aspirated during OPU(1 day)
- Level of FSH hormone in the follicular fluid of follicles aspirated during OPU(1 day)
- Level of LH hormone in the follicular fluid of follicles aspirated during OPU(1 day)
研究者
Barbara Lawrenz
Scientific Director
ART Fertility Clinics LLC