PRP Improves Blastocyst Formation in ICSI Cycles (PRP ICSI SOAT)
2026年5月5日 更新者：Binarwan Halim、Stella Maris Women and Children Hospital
Efficacy of Platelet-rich Plasma on Blastocyst Formation in ICSI Cycles Involving Low-quality Sperm: A Randomised Study
The goal of this clinical trial is to learn if platelet rich plasma (PRP) works to improve embryo development rates and embryo quality in IVF cycles, involving male adult patients with severe sperm disorders.
The main questions it aims to answer are:
- Does PRP improve sperm quality of male adult patients undergoing IVF?
- Does PRP improve embryo development and embryo quality of the IVF patients?
Researchers will compare embryos from IVF patients treated with PRP to those not treated with PRP to see if PRP improves embryo development and embryo quality.
Participants will:
- Provide semen sample for IVF
- Provide blood sample for PRP preparation
- Have PRP obtained from their blood added to their sperm sample
研究概览
地位
完全的
条件
干预/治疗
研究类型
介入性
注册 (实际的)
66
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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North Sumatra
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Medan、North Sumatra、印度尼西亚、20152
- Halim Fertility Center, RSIA Stella Maris lantai 5, Jl. Samanhudi No.20, J A T I, Kec. Medan Maimun, Kota Medan, Sumatera Utara 20152
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- sperm concentration of less than five million/mL;
- total sperm motility < 42%;
- sperm normal morphology of less than four percent;
- provided informed consent to participate in the study
Exclusion Criteria:
- leukospermia;
- a history of HIV, hepatitis, or other reproductive tract infections;
- a history of utilising drugs or therapies within the past three months, such as antibiotics, radiotherapy, chemotherapy, psychiatric medications, or anabolic steroids;
- a history of fever within the past three months;
- a history of testicular carcinoma;
- using a second ejaculate sample for ICSI;
- using a cryopreserved semen sample for ICSI;
- a history of retrograde ejaculation;
- a history of coagulopathy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：富血小板血浆
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Platelet-rich plasma (PRP) will be prepared from autologous blood collected from each participant.
The blood sample will undergo centrifugation at 1400 rpm for 15 minutes to separate and concentrate the platelet-rich fraction.
The resulting PRP will then be isolated and added to the participant's sperm sample for use in the IVF procedure.
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无干预：Non-PRP
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blastocyst formation rate (%)
大体时间：From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Blastocyst formation rate is defined as the proportion of fertilised oocytes that successfully develop into blastocysts by Day 5 of embryo culture.
It is calculated as the number of embryos reaching the blastocyst stage on Day 5 divided by the total number of normally fertilised oocytes (2 pronuclei, 2PN), expressed as a percentage.
Embryo development is assessed using standard morphological criteria under microscopy, and only embryos meeting established blastocyst-stage characteristics are included in the numerator.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fertilisation rate (%)
大体时间：From enrollment to fertilisation of the embryo (day 1). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fertilisation rate refers to the percentage of mature eggs that are successfully fertilised after being combined with sperm in the laboratory.
It is calculated by dividing the number of eggs that show normal signs of fertilisation by the total number of mature eggs used for insemination, then multiplying by 100.
Normal fertilisation is identified by the presence of two distinct structures inside the egg when examined under a microscope approximately 16-18 hours after insemination.
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From enrollment to fertilisation of the embryo (day 1). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Cleavage rate (%)
大体时间：From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Cleavage rate refers to the percentage of fertilised eggs that undergo early cell division during the first 3 days of embryo development.
It is calculated by dividing the number of fertilised eggs that successfully divide into two or more cells by the total number of normally fertilised eggs, then multiplying by 100.
Embryos are observed under a microscope to confirm cell division and early development.
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From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Good-quality blastocyst (%)
大体时间：From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Good quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for high quality based on their appearance under a microscope.
It is calculated by dividing the number of blastocysts classified as good quality by the total number of blastocysts formed, then multiplying by 100.
Blastocyst quality is assessed using standard grading systems that evaluate the degree of expansion, the appearance of the inner cell mass and the outer cell layer.
Only blastocysts meeting the predefined criteria for good quality are included.
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From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fair-quality blastocyst (%)
大体时间：From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fair quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for intermediate (fair) quality based on their appearance under a microscope.
It is calculated by dividing the number of blastocysts classified as fair quality by the total number of blastocysts formed, then multiplying by 100.
Blastocyst quality is assessed using standard grading systems that evaluate how expanded the blastocyst is, the appearance of its inner cell mass and outer cell layer.
Only blastocysts meeting the predefined criteria for fair quality are included.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Poor-quality blastocyst (%)
大体时间：From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Poor quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 but are classified as low quality based on their appearance under a microscope.
It is calculated by dividing the number of blastocysts assessed as poor quality by the total number of blastocysts formed, then multiplying by 100.
Blastocyst quality is evaluated using standard grading criteria that consider the degree of expansion, the appearance of the inner cell mass and the outer cell layer.
Blastocysts that show limited expansion or irregular or poorly defined structures are classified as poor quality.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年1月1日
初级完成 (实际的)
2023年8月30日
研究完成 (实际的)
2023年12月30日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年1月1日
更多信息
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