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临床试验/CTRI/2021/02/031447
CTRI/2021/02/031447尚未招募不适用

Comparison of perifollicular and endometrial vascularity in patients undergoing ovulation induction with Clomiphene citrate and Letrozole

Kasturba Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2021年2月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
190
试验地点
1
主要终点
effect of clomiphene citrate and letrozole on perifollicular and endometrial vascularity

研究概览

简要总结

Prospective observational study will be conducted in Kasturba Hospital, Manipal. Ethical clearance by Institutional Ethical Committee (IEC), Kasturba Hospital is taken. Women undergoing infertility treatment with ovulation induction will be screened for inclusion and exclusion criteria through proforma where baseline demographic characteristics will be obtained. A written informed consent from the participants will be taken after a brief explanation about the procedure.

Cases will be divided into two groups based on treatment they are prescribed by their consultant. Group A (n= 95)will consist of patients who will receive treatment cycles with 50mg Clomiphene citrate from day 2 to day 6 of menstrual cycle. Group B (n= 95) will consist of patients who will receive treatment cycles with Letrozole 2.5mg from day 2 to day 6 of menstraul cycle.

In both the groups endometrial and follicular vascularity will be assessed by transvaginal doppler ultrasound on the 11th day of menstrual cycle. The dominant or largest follicle, together with all follicles>18mm in diameter will be graded using power doppler.

This grading system will be based on the percentage of perifollicular circumference that will depict an echo signal and will range from grades:

  1. grade 0- no detectable blood flow

  2. grade 1- visible blood flow in 1-25% of follicular circumference

  3. grade 2- blood flow in 26-50% of follicular circumference

  4. grade 3- blood flow in 51-75% of follicullar circumference

  5. grade 4- blood flow in 76-100% of follicular circumference

Endometrial vascularity will be graded as-

Type A- Homogenous pattern, defined as a single hyperechoic, hypoechoic or isoechoic layer with absent or poorly defined central echogenic line

Type B- Triple line pattern, defined as multi-layered endometrium consisting of a prominent outer and inner hyper-echoic line and inner hypoechoic regions

All data will be recorded in an Excel sheet.

Using Mann-Whitney U test, statistical analysis will be done to compare the perifollicular and endometrial vascularity between the two treatment groups.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women undergoing Ovulation induction with Clomiphene citrate or Letrozole.

排除标准

  • Women undergoing any other form of infertility treatment.
  • Other causes of infertility will be excluded by documentation of a normal uterine cavity, atleast one patent fallopian tube and current partner having a normal semen analysis report.

结局指标

主要结局

effect of clomiphene citrate and letrozole on perifollicular and endometrial vascularity

时间窗: 12 months

次要结局

  • Ovulation rate and pregnancy rate in patients treated with clomiphene citrate and letrozole(12 months)

研究者

申办方类型
Private medical college

研究点 (1)

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