Effect of Low Molecular Weight Heparin (Bemiparin) on Implantation Rate in Patients With Recurrent Implantation Failure Undergoing IVF/ICSI - A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Implantation rate (%)
研究概览
简要总结
The objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment.
详细描述
Recurrent implantation failure (RIF), defined as failure of conception following three or more consecutive In Vitro Fertilization (IVF) cycles despite the transfer of good quality embryos, is a major cause of distress amongst infertile couples. While factors underlying implantation failure are many, most cases remain unexplained. In order to improve pregnancy outcomes and delivery rates in women with unexplained RIF, various investigational treatments have been proposed.
The investigators propose a prospective controlled randomized comparative study to evaluate the effect of Bemiparin on implantation rates in women with unexplained RIF. A total of 200 patients will be recruited and randomized between two groups. The study group will receive Bemiparin plus standard care; while the control group will receive only standard care. Treatment will start on the day following embryo transfer and will be continued until 12 weeks gestation in the event of pregnancy.
The primary objective is to determine the effect of Bemiparin on implantation rate in women with unexplained recurrent implantation failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer.
- •Normal uterine cavity (as assessed by hysteroscopy or HSG).
- •Normal hormonal investigation: TSH, PRL, FBS.
- •Normal acquired/inherited thrombophilia profile: LAC, ACA IgG/IgM, Prot S, Antithrombin III, beta-2 glycoprotein, Factors V, II, MTHFR.
- •Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%.
- •Patient provides written informed consent.
排除标准
- •Evidence of low ovarian reserve by at least one of the following: AMH ≤ 1,5 ng/mL and/or basal CD 3 FSH ≥ 10 mIU/mL and/or basal CD 3 Estradiol ≥ 60 ng/mL and/or previous egg collection yield ≤ 3 oocytes.
- •Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition...).
- •Severe male factor infertility (Total motile sperm count < 5 million/ml and/or normal WHO morphology <20%).
- •Hypersensitivity to Heparin or its derivatives.
- •Acquired thrombophilia.
- •Active hemorrhage or increased risk of bleeding due to impairment of homeostasis.
- •Severe impairment of liver or pancreatic function.
- •Severe renal insufficiency (Creatinine Clearance < 30 ml/min).
- •Injuries to or operations on the central nervous system, eyes and ears within the last 2 months.
- •Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.
- •Acute bacterial endocarditis and endocarditis lenta.
- •Any organic lesion with high risk of bleeding (e.g.: active peptic ulcer, hemorrhagic stroke, cerebral aneurysm or cerebral neoplasms).
研究组 & 干预措施
Low molecular weight heparin
Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes.
干预措施: Bemiparin sodium (Drug)
结局指标
主要结局
Implantation rate (%)
时间窗: Vaginal ultrasound at 8 weeks gestation
Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos
次要结局
- Total pregnancy rate (%)(Up to 15 days from oocyte collection)
- Clinical pregnancy rate (%)(Vaginal ultrasound at 8 weeks gestation)
- Live birth rate (%)(Time of delivery up to 42 weeks gestation)
- Ongoing pregnancy rate (%)(Vaginal ultrasound at 20 weeks of gestation)
研究者
Johnny Awwad
Professor of Obstetrics and Gynecology
American University of Beirut Medical Center