Intrauterine instillation of autologous platelet rich plasma in infertile females with thin endometrium undergoing intrauterine insemination
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
- 1)Change in endometrium thickness.
研究概览
简要总结
Background and Rationale
Appropriate endometrial thickness is essential for a successful pregnancy. Women with persistent thin endometrium lining in infertility programs particularly those resistant to standard therapies pose a significant clinical challenge.
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.Of these, effect of estrogen is the most studies and widely used. But patients with refractory thin endometrium don’t have many options. Recently there has been use of cell proliferation method using stem cell therapy.ut there are still some unsolved issues regarding safety and usability of bone-marrow derived stem cells.Autologous Platelet rich plasma is one such option.
The autologous PRP instilled in the endometrial cavity, results in regeneration of endometrium thereby resuming/improving menstrual bleeding and allowing implantation of fertilized ovum. 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 achieving menstrual and clinical pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 37.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Infertile female between 21-37 years with normal ovarian reserve (AMH:1.2-4 ng/ml;AFC:5-15) , patent both tubes and normal seminogram/ or mild male factor undergoing IUI for mild cervical factor and/ or unexplained infertility.
- •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 and 3 ovulatory dysfunction 8.Mullerian abnormality 9.Ashermann Syndrome 10.Endometritis 11.Moderate /severe endometriosis 12.Active vaginal/cervix infection/pelvic inflammatory disease.
- •13.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
1)Change in endometrium thickness.
时间窗: 1)baseline,36-40 hours | 2)baseline,36-40 hours
2)change in endometrium vascularity
时间窗: 1)baseline,36-40 hours | 2)baseline,36-40 hours
次要结局
- 1)positive pregnancy rate(2)clinical pregnancy rate)