跳至主要内容
临床试验/CTRI/2024/11/076262
CTRI/2024/11/076262尚未招募Phase 3 4

Effect of Endometrial Perfusion of Platelet Rich Plasma (PRP) on success of Frozen Embryo Transfer (FET)

Datta Meghe Institute Of Higher Education And Research,Sawangi Meghe, Wardha India 4420011 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月5日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Rate of positive Beta HCG , positive UPT, appearance of gestational sac and cardiac activity on USG

研究概览

简要总结

The assisted reproductive technology (ART) method of frozen embryo transfer (FET) is now often used to produce healthy babies. Adjunctive medications to enhance endometrial receptivity are being investigated, nevertheless, because implantation failure continues to be a major obstacle. Endometrial perfusion and responsiveness may be modulated by platelet-rich plasma (PRP), which is abundant in growth factors and cytokines.  In order to assess the impact of PRP endometrial perfusion on the success of frozen embryo transfer, this abstract undertakes a meta-analysis of the literature. Research examining the effect of PRP on FET outcomes was included in the eligible papers, which also included prospective cohort studies and retrospective analyses.  When comparing the clinical pregnancy rates of women undergoing FET with endometrial perfusion of PRP to controls, a pooled analysis of data from specific studies shows a substantial improvement (p < 0.05). Moreover, a dose-response relationship is suggested by the positive association shown by meta-regression analysis between the concentration of platelets in PRP and pregnancy outcomes. Subgroup studies that take into account the patient’s demographics, the cause of their infertility, and the methods used to prepare PRP offer valuable information on possible causes of heterogeneity and variances in treatment outcomes. Notably, there is no discernible rise in adverse events recorded across studies, suggesting that PRP treatment has a positive safety profile.  Although the results indicate that PRP may be useful in improving endometrial receptivity and FET success, there are a number of limitations that should be taken into consideration when interpreting the results. These include limited sample sizes, heterogeneity in study designs, and variability in PRP preparation techniques. Larger sample sizes and more carefully planned RCTs are required in the future to confirm these results and clarify the best PRP delivery schedule for enhancing FET outcomes.  To sum up, endometrial perfusion of PRP exhibits potential as a viable adjuvant therapy to augment the effectiveness of frozen embryo transfer, providing fresh opportunities to improve patient outcomes and pregnancy rates in assisted reproductive environments.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Women aged 18- 45 yrs 2.The lack of contraindications for PRP treatment ( Hb-less than 10gm%, low platelet count, sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia anf congenital fructose intolerance) 3.Women with a normal transvaginal ultrasound and no evidence of a clinically significant abnormality in the uterus or adnexa.
  • 4.Negative CBNAAT, AFB staining and TBPCR for genital tuberculosis.

排除标准

  • 1.Patients with BMI greater than 30 kg/m2 2.Positive history of intrauterine synechiae, repeated currettage, endometrial injury 3.Distorted endometrial cavity because of recurrent adhesions, submucosal fibroids, endometrial polyps, severe endometriosis, adenomyosis, pelvic cancer and uterine anomalies.
  • 4.Chromosomal abnormalities in couples.
  • 5.Patients with abnormal liver and kidney function, abnormal thyroid function, immune disorders or hematological disorders.

结局指标

主要结局

Rate of positive Beta HCG , positive UPT, appearance of gestational sac and cardiac activity on USG

时间窗: Assessment will be done after 4 weeks

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute Of Higher Education And Research,Sawangi Meghe, Wardha India 442001
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Khushboo Shah

Datta Meghe institute of higher education and research

研究点 (1)

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