Intrauterine instillation of autologous Platelet rich plasma in infertile females with thin endometrium undergoing intrauterine insemination: a prospective interventional study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Thin or damaged endometrium remains to be a challenge in treatment of patients with infertility.Several treatment to restore endometrial thickness have been attempted e.g. exogenous estrogen,vitamin E,Sildenafil citrate and pentoxifylline.But patients with refractory thin endometrium don’t have many options. Recently there has been use of cell proliferation method using stem cell therapy.Autologous Platelet rich plasma is one such option.Platelet Rich Plasma(PRP) is blood plasma prepared from fresh whole blood which is enriched with platelets. It contains several growth factors like VEGF,FGF,EGF,PDGF,TGF and other cytokines that stimulate proliferation and growth.
The main mechanism of action is by platelet aggregation upon activation which releases intracytoplasmic granules. Activated platelets release granules by exocytosis which contain more than sixty different biologically active substances that are involved in process of tissue regeneration, angiogenesis and epithelization.
The aim of the study is to assess if intrauterine administration of autologous Platelet Rich Plasma improves endometrial thickness and vascularity in females with thin endometrium and results in improving menstruation and achieving clinical pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 37.00 Year(s)（—）
- 性别
- Female
入选标准
- •Infertile female between 21-37 years.
- •Persistent thin endometrial thickness ≤6 mm on ≥1 cycle in previous cycle even after conventional treatment with estradiol valearate.
- •HB>11 gm% and platelets>1.5 lakhs.
排除标准
- •1.History of symptoms of platelet dysfunction such as easy bruisability, frequent nose-bleeds, heavy menstrual bleeding, bleeding gums or excessive bleeding during dental procedures.
- •2.Blood borne disease like Hepatitis B, Hepatitis C, Syphilis, HIV.
- •3.NSAIDs intake in 10 days before the procedure 4.Pt on anticoagulant therapy 5.Severe Male factor for infertility 6.Tubal factor for infertility 7.WHO class 1 or 3 ovulatory dysfunction 8.Mullerian abnormality 9.Ashermann Syndrome 10.Moderate /severe endometriosis 11.Active vaginal/cervix infection/pelvic inflammatory disease.
- •12.Any significant co-morbidity/ psychiatric disorder which compromise or interfere with consent giving/study participation/ follow up or interpretation of study.
结局指标
主要结局
Primary Outcome
时间窗: 36-40 hours post PRP instillation
1)Change in endometrium thickness.
时间窗: 36-40 hours post PRP instillation
2)change in endometrium vascularity
时间窗: 36-40 hours post PRP instillation
次要结局
- Secondary outcome(1)positive pregnancy rate)