Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- Number of Euploid Embryos
研究概览
简要总结
The PPOS protocol (Progestin-primed Ovarian Stimulation) involves avoiding ovulation during ovarian stimulation with progesterone. It is a reliable and safe protocol that has been widely used in recent years for in vitro fertilization, as it reduces the number of injections needed during controlled ovarian stimulation and is more cost-effective for patients.
The aim of this study is to compare two methods of ovarian stimulation for in vitro fertilization: the PPOS protocol (Group A) and the conventional protocol with injected antagonists (Group B). The goal is to determine whether both methods are equally effective in obtaining euploid embryos in the context of double ovarian stimulation.
详细描述
Hypothesis:
Hypothesis: The number of euploid embryos obtained in a DUOSTIM cycle with PPOS is not inferior to that obtained with the use of antagonists.
General and Specific Objectives
Main Objective: To study if there is a difference in the number of euploid embryos obtained in two groups of patients undergoing embryo accumulation for PGT-A through double ovarian stimulation, comparing two methods of pituitary suppression: Progesterone use from the start of stimulation and the use of GnRH antagonists.
Secondary Objectives:
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regular menstrual cycles between 21 and 35 days, inclusive.
- •Indication of IVF with PGT-A.
- •Both ovaries present.
- •Ability to participate and complete the study.
- •Give and sign the consent to participate in the study.
排除标准
- •Endometriosis grade III/IV
- •Concurrent participation in another study
研究组 & 干预措施
PPOS - study group
Patients belonging to this arm will initiate controlled ovarian stimulation by administering FSHr gonadotropin at doses between 225 IU-300 IU/day (according to patient characteristics) + 10mg medroxyprogesterone/day (IMP) from day 2-3 of their menstrual cycle.
Both groups will continue with the usual regimen of administration of all medications related to Ovarian Stimulation
干预措施: Medroxyprogesterone Acetate 10 MG (Drug)
GnRH antagonists - control group
Patients belonging to this arm will initiate controlled ovarian stimulation by administering FSHr gonadotropin at doses between 225 IU-300 IU/day (according to patient characteristics) from day 2-3 of their menstrual cycle, and treatment with the GnRH antagonist at a dose of 0.25 mg/day from the 6th day of stimulation or when a follicle with a size equal to or greater than 14mm is present. Both groups will continue with the usual regimen of administration of all medications related to Ovarian Stimulation
干预措施: Ganirelix (Drug)
结局指标
主要结局
Number of Euploid Embryos
时间窗: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Total number of euploid embryos after the two egg retrievals
次要结局
- Number of Oocytes retrieved(From date of randomization until the end of the treatment. Assessed up to 12 weeks.)
- Number of Metaphase II oovcytes(From date of randomization until the end of the treatment. Assessed up to 12 weeks.)
- Number of Fertilized Oovytes(From date of randomization until the end of the treatment. Assessed up to 12 weeks.)
- Number of Blastocysts(From date of randomization until the end of the treatment. Assessed up to 12 weeks.)