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临床试验/NCT01340560
NCT01340560已完成不适用

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

Selcuk University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2010年9月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (2)

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