the Effect of Hyaluronic Acid Platelets Rich Plasma on the Endometrial Receptivity and Intracytoplasmic Sperms Injection Outcome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- measuring the value of resistance index (RI) of the sub-endometrial blood vessels
研究概览
简要总结
Hyaluronic acid intrauterine wash is done for infertile females undergoing intracytoplasmic sperm injection on the day of oocyte retrieval. endometrial receptivity parameters, including the subendometrial vasculature indices were measured before and after the intervention for purpose of studying the effect of hyaluronic acid on improvement of the endometrial receptivity and subsequently the pregnancy outcome
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
- Single (Participant)
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
- •Infertile females aged 18-40 years.
- •Infertile females scheduled for GnRH antagonist protocol of fresh ICSI cycle.
- •Females use dual stimulation (GnRH agonist plus Ovetrelle) for ovulation triggering.
排除标准
- •Infertile females diagnosed as a poor responder.
- •Infertile females diagnosed with uterine pathology.
- •Infertile females who are scheduled for a frozen ICSI cycle.
- •Infertile females diagnosed with endocrine diseases like thyroid disease, diabetes mellitus, and hyperprolactinemia.
- •Infertile females diagnosed with thrombocytopenia.
研究组 & 干预措施
the uterine cavity washed with hyaluronic acid preparation on the day of ooc
40 infertile patients had their uterine cavity with hyaluronic acid preparation on the day of oocytes retrieval in ICSI
干预措施: Hyaluronic Acid (HA) (Drug)
40 infertile females had their uterine cavity washed with PRP preparation
40 infertile females had their uterine cavity washed with PRP preparation on the day of oocytes retrieval in ICSI
干预措施: platlet rich plasma (PRP) (Drug)
结局指标
主要结局
measuring the value of resistance index (RI) of the sub-endometrial blood vessels
时间窗: for each participant twice measure will be done for (RI). The first measure will be performed on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval.
We will measure the value of the resistance index (RI) using the transvaginal ultrasound Doppler study. For each patient, RI will be measured twice: the first measure will be done before the intervention on the day of oocyte retrieval, and the second measure will be performed after the intervention on the day of embryo transfer. we will calculate RI according to the following equation Resistance index (RI)= \[Peak Systolic Velocity (PSV) cm/sec - End Diastolic Velocity (EDV) cm/sec \] / Peak Systolic Velocity (PSV) cm/sec Then a statistical comparison will be made to evaluate the difference between the two readings to study the effect of the intervention on the measured parameter for each group.
measuring the value of sub- endometrial vessels pulsatile index (PI)
时间窗: for each participant twice measure will be done for PI. The first measure is on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval.
We will measure the value of the pulsatile index (PI) using the transvaginal ultrasound Doppler study. PI will be measured twice for each patient: once before the oocyte retrieval intervention and once after the embryo transfer intervention. then PI will be calculated according to the following equation Pulsatility Index (PI) = \[Peak Systolic Velocity (PSV) cm/sec - end Diastolic Velocity (EDV) cm/sec \] / Mean Velocity (MV) cm/sec Then a statistical comparison will be made to evaluate the difference between the two readings to study the effect of the intervention on the measured parameter for each group.
measuring the value of peak systolic to end diastolic ratio (S/D) of the sub-endometrial blood vessels
时间窗: for each participant twice measure will be done for S/D. The first measure is on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval.
We will measure the value of the peak systolic to end diastolic ratio (S/D) using the transvaginal ultrasound Doppler study. For each patient, S/D will be measured twice: the first measure will be done before the intervention on the day of oocyte retrieval, and the second measure will be performed after the intervention on the day of embryo transfer. S/D will be calculated according to the following equation S/D= Peak Systolic Velocity (PSV) cm/sec /End Diastolic Velocity (ED) cm/sec Then a statistical comparison will be made to evaluate the difference between the two readings to study the effect of the intervention on the measured parameter for each group.
次要结局
- measuring serum level of beta human chorionic gonadotropin(2 weeks from the day of oocyte retrieval)
研究者
ghada bassim raaf
clinical professor
Al-Nahrain University