Endometrial Local Injury to Improve the Outcome of Embryo Transfer

Overview

The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism.

Full Title of Study: “Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2017

Detailed Description

It is important to evaluate the efficacy of endometrial local injury in assisted reproductive technology(ART),especially on the patients of recurrent implantation failure. Although most trials proved the effectiveness of the intervention of local injury, the subjects of these trials are rarely the patients of repeated implantation failure(RIF). Moreover, the mechanism of endometrial injury is not clear.Our trial may provide further basis for this purpose by comparing to the quality of endometrium in two-dimensional ultrasound.If the technique demonstrates efficacy, it would help the patients with RIF caused by poor conditions of endometrium to deal with the problem of infertility.

Interventions

  • Procedure: Endometrial local injury
    • The way of intervention is to scratch the uterine cavity two cycles by a small spatula in the first 3-5 days after menstrual period.

Arms, Groups and Cohorts

  • Experimental: Endometrial local injury
    • Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.
  • No Intervention: The blank group
    • Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy.

Clinical Trial Outcome Measures

Primary Measures

  • implantation rate
    • Time Frame: 3 months after intervention
    • When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.

Secondary Measures

  • the change of three-dimensional ultrasound of uterine cavity before and after intervention
    • Time Frame: in implantation window period(12-14 days)
    • including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index.
  • clinical pregnancy rate
    • Time Frame: an expected average of 7 week after pregnancy
    • The standards is to detect fetal heart beat by ultrasound.
  • live birth rate
    • Time Frame: follow-up for one year after pregnancy
    • The statistical ratio of live birth rate in two groups
  • the rate of birth defects
    • Time Frame: follow-up for one year after pregnancy
    • calculate the rate of birth defects in two groups
  • the expression changes of endometrial inflammatory factors
    • Time Frame: endometrial sampling after local injury ,in the first 3-5 days after menstrual period
    • Detection of inflammatory factors, such as LIF,MIP-1. —————————
  • infection rate
    • Time Frame: one week after intervention
    • detection of infection by serum test

Participating in This Clinical Trial

Inclusion Criteria

  • Women with RIF(≥2) of embyo transfer and uneven echo of endometrium on HCG day(12-14 days) – Without operation history of uterine cavity in the previous three months – Who agree to join in the study Exclusion Criteria:

  • Women more than 40 years or less than 20 years – With infectious diseases or endocrine diseases – Who refuse to participate in the experiment

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Navy General Hospital, Beijing
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yunhai Chuai, Department of Obstetrics and Gynecology, Navy General Hospital, Beijing – Navy General Hospital, Beijing
  • Overall Official(s)
    • Aiming Wang, Dr, Principal Investigator, Navy General Hospital, Beijing
  • Overall Contact(s)
    • Yi Li, +8613548550909, 51261886@qq.com

References

El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26.

Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.

Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.

Citations Reporting on Results

Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.

Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.

Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.

Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3.

Parsanezhad ME, Dadras N, Maharlouei N, Neghahban L, Keramati P, Amini M. Pregnancy rate after endometrial injury in couples with unexplained infertility: A randomized clinical trial. Iran J Reprod Med. 2013 Nov;11(11):869-74.

Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.

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