The Effect of Local Injury to the Endometrium for Implantation and Pregnancy Rates in ICSI -ET Cycles With Recurrent Implantation Failure: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Implantation ratio
研究概览
简要总结
Objective To evaluate the effect of local injury to the endometrium for implantation, pregnancy and live birth rates in ICSI -ET cycles with recurrent implantation failure.
Design Randomized controlled clinical study. Setting A clinical will assist reproductive center of Selcuk University Meram Medical Faculty Hospital in the Konya, Turkey.
Population A group of 100 women, who failed to conceive during one or more cycles of IVF and embryo transfer (ET), will treat with a long protocol for controlled ovarian hyperstimulation.
Methods The IVF treatment and ET will precede by repeated endometrial biopsies, in a randomly selected 50 of a total of 100 women.
详细描述
The clinical study will take place in clinical assisted reproductive center of Selcuk University Meram Medical Faculty Hospital in the Konya, Turkey. A group of 100 women who apply to our clinic due to infertility and who undergo one or more failed fresh IVF cycles previously will be included in our study for ICSI-ET (intracytoplasmic sperm injection-embryo transfer).
We will exclude women with factors as hydrosalpinx, trombophilia, submucous myoma and found to have a negative impact on implantation. Women will be given information about the study, and written informed consents will be obtained. Our study also received approval of ethic committee of our faculty.
Women of the study group (n=50) will randomly selected. The random allocation will base on computer generated random numbers. All 100 women will treate with long protocol for COH (control group=group 1, n=50 and study group=group 2, n=50.
On the other hand, the women in the study group (group 2, n=50) will undergo endometrial biopsies with one-week intervals at the luteal phase of nontransfer cycle. Endometrial biopsy will performe with biopsy catheter (Pipelle; de Cornier, Prodimed, Neuilly-en-Thelle, France). The catheter will be passed through the cervical os and will rotate in uterine cavity and apply 3-4 times after withdrawing the piston.
Treatment schedules Administration of Leuprolide acetate (Lucrin; Abbott, France) at a subcutaneous dose of 1 mg/day will be started at the 21st day of menstrual cycle on the patient selected for therapy. All of the women will be protected by one of non-hormonal contraception method during this cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 36 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women who applied to our clinic due to infertility and who undergone one or more failed fresh IVF cycles previously has been included in our study for ICSI-ET (intracytoplasmic sperm injection-embryo transfer).
排除标准
- •women with factors as hydrosalpenx, trombophilia, submucous myoma and found to have a negative impact on implantation
结局指标
主要结局
Implantation ratio
时间窗: Six months
Implantation ratios were 30.88% in Group 1 and 34.67% in Group 2 (p =0.13). So there wasn't any significant difference for implantation ratios between two groups, but implantation ratio of 34.67% in Group 2 was evaluated as clinically significant
Clinical pregnancy ratio
时间窗: six months
Cardiac activity on USG for clinical pregnancy were determined in seventeen women of the control group (34%) and 30 women of the study group (60%). The clinical pregnancy rate was significiantly higher in the study group with compared to control group (p=0.009)
Live birth ratio
时间窗: six months
Twenty two of the 30 pregnancies in the study group ended in the delivery of 27 healthy babies. This stituation represents a rate of live births in the study group that was significiantly higher than control group (44% and 24%) (p= 0.03)
次要结局
- Implantation ratio(six months)
- Clinical pregnancy ratio(six months)
- Live birth ratio(six months)
