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临床试验/CTRI/2018/03/012452
CTRI/2018/03/012452尚未招募不适用

Assessment of endometrial receptivity using Doppler ultrasonography in infertile women in controlled ovarian stimulation

Council of scientific and industrial research ministry of science technology Government of India1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年12月3日最近更新:

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:ʉۢTo 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: â€¢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

研究者

发起方
Council of scientific and industrial research ministry of science technology Government of India
申办方类型
Research institution

研究点 (1)

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