2023-507028-22-00招募中4 期
The impact of ovarian stimulation intensity on embryo euploidy in advanced age women. A randomized controlled trial
Santiago Dexeus Font Fundacio Privada1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年11月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol
研究概览
简要总结
To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients with indication for IVF
- •Undergoing preimplantation genetic screening cycles
- •Age >= 38 and < 42 years old
- •AMH > 1.5 ng/ml and < 3.5 ng/ml (AMH result of up to one year will be valid)
- •BMI 18.5 – 30 Kg/m2
排除标准
- •Severe male factor requiring TESE (testicular sperm extraction)
- •Administration of any other drug potentially interfering with the treatment
- •Contraindication for hormonal treatment
- •Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
- •Monogenic disease to be detected with PGT-M
结局指标
主要结局
To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol
To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol
次要结局
- Total gonadotropin dose and length of stimulation
- Number of oocytes and mature oocytes (MIIs) retrieved
- Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH)
- Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation).
- Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation).
- Cycle cancelation rate
- Reason for cycle cancelation
- Fertilization rate
- Time of appearance of the 2nd polar body (tPB2)
- Time of pronuclei appearance (tPNa)
- Evaluation of both pronuclei (PN)
- Time of pronuclei disappearance (tPNf)
- Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
- Time of compactation (tSC)
- Time of morula (tM)
- Time of cavitation (tSB)
- Time of full blastulation (tB)
- Total number of day 5 blastocysts
- Total number of good quality blastocysts
- Total number of embryos
- Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage
- Number of embryos cryopreserved
- Embryo stage (D5, D6, D7)
- Clinical pregnancy rate, defined as the visualization of one or more gestational sacs
- Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8-10 weeks duration confirmed on an ultrasound scan
研究者
Unidad Soporte Investigación
Scientific
Santiago Dexeus Font Fundacio Privada
研究点 (1)
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