The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- positive bHCG rate
研究概览
简要总结
The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.
详细描述
Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Personal history of 2 or more failed IVF/ICSI cycles (RIF)
- •* Age\2)
排除标准
- •Personal history of endometrial tuberculosis/ antituberculous treatment
- •Sonographically detected hydrosalpinges
- •Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
- •Thrombophilia
研究组 & 干预措施
Endometrial injury by hysteroscopy or pipelle sapling
Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.
干预措施: Endometrial injury by hysteroscopy or pipelle sampling (Procedure)
COH for IVF without hysteroscopy or pipelle sampling
Procedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied.
干预措施: Proceed to COH directly (Procedure)
结局指标
主要结局
positive bHCG rate
时间窗: through study completion, an average of 2 years
次要结局
- Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)(2 years)
- live birth rate(2 years)
- clinical pregnancy rate(2 years)
- Ectopic pregnancy rate(2 years)
- Miscarriage rate(2 years)
- Ongoing pregnancy rate(2 years)
研究者
Siristatidis Charalampos, MD, PhD
Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction
National and Kapodistrian University of Athens