A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 主要终点
- The fertilization rate/per patient.
研究概览
简要总结
this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.
详细描述
A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.
Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.
Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).
- •Age less than 40 years old.
- •Primary infertility for 2 years and secondary infertility for 1 year.
排除标准
- •Non-PCO patients as:
- •Congenital adrenal hyperplasia
- •Hyperprolactinemia.
- •Recurrent implantation failure.
- •Hydrosalpinx.
- •Uterine pathology.
- •Uncontrolled medical disorder eg DM, HTN
- •Male factor infertility.
研究组 & 干预措施
Progesterone primed ovarian stimulation protocol.
Group (A): Women in progesterone primed (PPOS) will be prescribed a 30 mg oral dose of dydrogesterone (Duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until the triggering day. Vaginal sonography will be done for all patients since 6th day of the cycle.
干预措施: Progesterone antagonist (Drug)
conventional antagonist protocol.
Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of Cetrotide (Merck-Serono, Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.
干预措施: conventional antagonist protocol (Drug)
结局指标
主要结局
The fertilization rate/per patient.
时间窗: 12 months
The number of fertilized oocyte by sperm
Number of frozen embryos/per patient
时间窗: 12 month
the number of embryo frozen
The number of oocytes retrieved per patient
时间窗: 12 months
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
The number of MII oocytes/per patient
时间窗: 12 months
the grade of maturity of oocyte under microscope
次要结局
- Incidence of early OHSS yes /no(12 months)
- Pregnancy outcomes(12 months)
研究者
rehab abdelhamid aboshama
associate professor of obstetrics and gynecology
Fayoum University