Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
100 patient of unexplained infertility recruited and divided into two groups for the study group (50) endometrial scratching done in preovulatory period after controlled ovarian stimulation by clomiphene citrate , then followed and compared to control group for 6 months to asses pregnancy rate
详细描述
Induction of ovulation was done by clomophine citrate (selective estrogen modulator of triphenylethylene group, produced by( Sanafi Aventis company) from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) produced by IBSA ( Institute biochimique SA) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size.
Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) produced by Jiangsu Guard King Medical Equipment Co.
The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle.
In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix.
Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus.
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
- None
入排标准
- 年龄范围
- 20 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unexplained infertility ( 1ry & 2ndry infertility) : *
- •Normal hormonal profile of infertile woman.
- •Normal hystrosalpingogram.
- •Normal laparoscopy.
- •Normal investigation of the cervical factor
- •Fertile semen analysis (according to world health organization criteria 2015).
排除标准
- •• Infertile semen analysis.
- •Abnormal HSG.
- •Abnormal laparoscopic findings.
- •Disturbed hormonal profile.
- •Evidence of cervical factor.
- •Known genetic disorder
- •Known autoimmune disease
研究组 & 干预措施
Scratch group
Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size.
Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle
干预措施: Clomiphene Citrate (Drug)
Scratch group
Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size.
Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle
干预措施: Human chorionic gonadotropin (Drug)
Scratch group
Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18_20mm in size.
Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle
干预措施: Endometrial scratch (Device)
Non scratch group
They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day
干预措施: Clomiphene Citrate (Drug)
Non scratch group
They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day
干预措施: Human chorionic gonadotropin (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 4 weeks after missed period
intrauterine gestational sac
次要结局
未报告次要终点