The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 716
- 主要终点
- Live birth Rate
研究概览
简要总结
The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.
详细描述
Inclusion criteria:
- patients undergoing 1st trial ICSI
- unexplained infertility
- negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA
Exclusion criteria:
- previous IVF/ICSI
- Any cause of infertility
- Suspected and/or unexpected poor response during ovulation induction
- positive immunological markers
- Age > 40 years.
All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 38 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age less than 38 years
- •at least 12 months of infertility
- •women with unexplained infertility
排除标准
- •age more than or equals 38 years
- •serum AMH level less than or equals 1 ng/ml
- •patients of anticoagulant therapy
- •immune-compromised patients
- •patients with contraindications to low molecular weight heparin
- •positive immunological markers
- •patients with other than unexplained infertility
- •male factor infertility
- •refusal of participation
- •patients with unexpected poor or over response during induction of ovulation
研究组 & 干预措施
LMWH supplementation
40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation
干预措施: LMWH (Drug)
0.9% saline solution
0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation
干预措施: 0.9% saline solution (Other)
结局指标
主要结局
Live birth Rate
时间窗: at delivery
次要结局
- Clinical Pregnancy Rate(at 7 weeks of gestation)
- Biochemical Pregnancy Rate(14 days after embryo transfer)
研究者
Mostafa Fouad Gomaa
Professor
Ain Shams University