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临床试验/NCT01977976
NCT01977976已完成不适用

A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing in Vitro Fertilization Treatment

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年4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
300
试验地点
1
主要终点
Ongoing pregnancy rate

研究概览

简要总结

Implantation failure remains one of the major factors limiting success in IVF treatment. It was postulated that the local injury to endometrium induces secretions of cytokines and growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding EGF-like growth factor which enhance decidualisation and facilitate implantation. It may also up-regulate the gene expressions related to endometrial receptivity and optimize the endometrial development. In stimulated cycles, local injury to the proliferative endometrium has been postulated to delay endometrial development thereby inducing synchronicity between endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al, 2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the on-going pregnancy rate in subfertile women undergoing IVF treatment.

详细描述

Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for IVF treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list. Patients will be stratified according to the first or repeated cycle.

For patients in the study group, in the cycle immediately preceding the scheduled IVF treatment, LH surge will be determined by daily serum LH level starting from 18 days before the next expected period. LH surge is defined as an elevation of LH to 2 times the level of the average of the previous 3 days and the absolute level of the LH should be more than or equal to 20 IU/L. Women randomized into the study group will have endometrial biopsy performed by pipelle 7 days after the LH surge (LH+7) and they will be instructed to use non-hormonal means of contraception during that cycle. All patients will then proceed to IVF treatment in the next cycle as scheduled. They will receive standard ovarian stimulation according to the departmental protocol and have a maximum of two embryos replaced 2 days after the oocyte retrieval. On-going pregnancy rates between the two groups will be compared.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing IVF for tubal, unexplained or male factor subfertility
  • Normal uterine cavity as shown on saline sonogram / hysteroscopy done at baseline

排除标准

  • Presence of hydrosalpinx
  • Presence of endometrial polyp or fibroid distorting uterine cavity
  • IVF cycles carried out for preimplantation genetic diagnosis
  • Use of donor gametes

结局指标

主要结局

Ongoing pregnancy rate

时间窗: 10-12 weeks gestation

Ongoing pregnancy rate per fresh embryo transfer

次要结局

  • implantation rate(4 weeks after embryo transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeung Wing Yee Tracy

Associate Consultant

The University of Hong Kong

研究点 (1)

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