Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 主要终点
- Implantation rate
研究概览
简要总结
Aim of this study is to compare the effectiveness of subendometrial PRP injection & intrauterine PRP infusion in women with recurrent implantation failure in comparison with a control group .
详细描述
This prospective randomized cotrolled study will be conducted in Private IVF centers in Minia governorate from January 2024 till December 2025,after being approved by the local Ethical committee of the department & written informed consent will be obtained from participants .
All patients will be counselled regarding inclusion in this study ,a written informed consent will be taken from each patient prior to participation in this study.
Recruited patients will be randomly allocated into 3 groups using opaque sealed closed envelops .
Sample size:
Based on previous studies & by using the sample size calculation of GPower software version 3.1.9.6 (Franz Faul, Kiel university, Germany), and setting β at 95% and α at 0.05. This makes sample size of 47 per each group. This figure will be rounded 25. Assuming a drop- out rate of 12%, this will make sample size 60 per each group.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 -40 years .
- •BMI<30 Kg/m
- •An IVF procedure resulting in at least one top quality embryo .
- •At least one cancelation history of embryo transfer due to thin endometrium (failure of achieving 7 mm endometrial thickness in the cycle) in frozen embryo transfer (FET) cycles after receiving standard hormone therapy.
- •Women had a history of failure to achieve pregnancy after two or more embryo transfers with high-quality embryos.
排除标准
- •women with other factors that may affect implantation success are excluded: ;
- •BMI >30 kg/m
- •Untreated uterine abnormalities.
- •untreated hydrosalpinges.
- •Thrombophilia.
- •uncontrolled endocrinopathy
- •severe male factor infertility.
- •difficult embryo transfer.
- •only poor quality embryos available .
- •couple with chromosomal abnormalities
- •Hematological disorders (blood cancer ,thrombocytopenia )
- •Hormonal disorders (DM,thyroid disorders )
- •Immunological disorders (anti phospholipid syndrome).
- •renal failure
- •Genetic ,chromosomal abnormalities
研究组 & 干预措施
Subendometrial PRP group
4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally & through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET.
干预措施: Platelet rich plasma (Biological)
Intrauterine infusion group
Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm.
干预措施: Platelet rich plasma (Biological)
Control group
will undergo standard FET with no intervention only hormonal preparation .
干预措施: No intervention /standard care (Other)
结局指标
主要结局
Implantation rate
时间窗: 5 weeks after embryo transfer
the ratio of gestational sacs to the number of embryos transferred .
次要结局
- Clinical pregnancy rate(5 weeks after embryo transfer)
- Chemical pregnancy rate(14 days after embryo transfer)
研究者
Mohamed mouner saber
Assistant lecturer
Minia University