Assessment of endometrial receptivity using Doppler ultrasonography in infertile women in controlled ovarian stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Aim: •To evaluate endometrial and subendometrial blood flow parameters in controlled ovarian stimulation cycles at the time of hCG trigger.
• To evaluate follicular vascularity in controlled ovarian stimulation cycles.
•To assess the relationship between endometrial, subendometrial,perifollicular blood flows and pregnancy outcome.
Material and method:
Prospective observational clinical study. Infertility Cases planned for controlled ovulation stimulation (COS) will be enrolled. They will be divided into 3 groups depending upon the protocol:
•Group 1- clomiphene citrate (CC)
•Group 2 - CC +HMG
•Group 3 -recombinant FSH /Gonadotrophin cycle
Ultrasound measurement of all patients will be performed from day 7 onwards. Ultrasound will be performed by investigator, on the day of hCG injection, once there is DF 20-22 mm with Clomiphene & 18 mm with gonadotrophins.
•The endometrial pattern & thickness will be noted.
•Endometrial & perifollicular blood flow will be studied.
•The findings will be correlated with pregnancy outcomes.
Endometrial thickness on the day of HCG injection (mm)
Morphology of endometrium : Type A Type B Type C
Uterine blood flow S/D PI RI
Endometrial blood flow Zone1: subendometrial, Zone2: midzone of endometrium. Zone 3: towards cavity
Group A-no endometrial blood flow
Group B-sudendometrial blood flow present
Group C -endometrial and subendometrial blood flow present
Perifollicular blood flows: F1 <25%, F2 -26%-50%, F3- 50%- 75%, F4 >75%
Categorical variables will be presented in number and percentage (%) and continuous variables will be presented as mean ± SD and median.
Qualitative variables will be correlated using Chi-Square test /Fisher’s exact test. A p value of <0.05 will be considered statistically significant.
The data will be entered in MS EXCEL spreadsheet and analysis will be done using Statistical Package for Social Sciences (SPSS) version 21.0.
Outcome: •Primary: Clinical pregnancy rate
•Secondary:Miscarriages, ectopic pregnancy
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 38.00 Year(s)(—)
- 性别
- Female
入选标准
- •All cases planned for controlled ovarian stimulation cycles.
- •Age 20-38 yrs Primary or secondary infertility.
排除标准
- •Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions, Asherman’s syndrome, bicornuate uterus, septate uterus) Women with acute vaginal and cervical infection Endometriosis and hydrosalpinx.
结局指标
主要结局
Clinical pregnancy rate
时间窗: 1year
次要结局
- Miscarriages, ectopic pregnancy
