JPRN-jRCTb070200001已完成2 期
Phase II Study on treatment for Infertility Patients with Implantation Failure using Autologous Adipose Tissue Derived Regenerative Cells - Phase II Study of ADRCs Therapy for Infertility
Miyamoto Shingo0 个研究点目标入组 1 人开始时间: 2020年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Intrauterine AMCUE infusion is safe procedure, however didn't demonstrate the positive effects of endometrial proliferation and implantation rate on infertility patients with implantation failure.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1)Patients who are diagnosed with infertility.
- •2)Patients who are suspected of embryo implantation failure.
- •3)Patients who require artificial reproductive technology.
- •4)Patients who have enough restoring potential to keep various organs ordinary condition. The data are acceptable within 3 months before the entry of clinical trial.
- •(1)White blood cell > 3,000/microl, Neutrophil > 1,000/microl
- •(2)Platelet > 100,000/microl
- •(3)Hemoglobin > 10.0 g/dl
- •(4)AST, ALT < 100 U/l (IU/l)
- •(5)Serum creatinine < 1.0 mg/dl
- •(6)Total bilirubin < 1.0 mg/dl
- •(7)Patients with no definite cardiac dysfunction
- •(8)Patients with D-Dimer <1.0 mg/dl or patients with D-Dimer >1.0 mg/dl and no deep vein thrombosis examined by lower extremity ultrasound
- •(9)PT <15 sec.
- •(10) APTT 24-38 sec.
- •5)Age => 20 years.
- •6)Patients who have the oocytes and blastocysts vitrified after insemination by sperm from her husband.
- •7)Patients and their husband who agree to attend this clinical trial by their own will.
排除标准
- •1)Patients who have serious illness or suspect to have serious illness mentioned below.
- •2)Patients who need psychotic therapy or who take psychiatric medication.
- •3)Patients with poorly-controlled diabetes.
- •4)Patients with active or poorly-controlled serious infection.
- •5)Patients with the diseases getting worse due to pregnancy.
- •6)Patients with inflammatory diseases or neoplastic lesion in endometrium.
- •7)Patients with serious drug hypersensitivity.
- •8)Patient with multiple malignancies or with those history 5 years (without intraepithelial neoplasm)
- •9)Patients who hope to use other oocytes and blastocysts, not their own oocytes and blastocysts.
- •10)Patient with malignancy or taking chemotherapy, radiation therapy or other cancer therapy.
- •11)Patients with serious diseases, for example, cardiac diseases, pulmonary diseases, liver diseases, kidney diseases, hemorrhagic diathesis, sepsis, poorly-controlled diabetes and hypertension and so on).
- •12)Patients who take anticoagulant or antiplatelet drugs, or inhibitors of GP IIb/IIIa.
- •13)Patients who take anticoagulant drug within 1 hour before harvesting their adipose tissues.
- •14)Patients with an elevated APTT more than 1.8 times of normal range.
- •15)Patients with active infection including HIV, syphilis, hepatitis B and C.
- •16)Pregnant women, nursing mothers, or patients with chance of pregnancy.
- •17)Patients undergoing other stem cell therapy.
- •18)Patient that principal investigator or sub investigators judged the participation in this clinical trial to be inappropriate.
研究者
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