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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial local injury | Experimental | Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy. |
|
| The blank group | No Intervention | Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial local injury | Procedure | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| implantation rate | When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation. | 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| the change of three-dimensional ultrasound of uterine cavity before and after intervention | including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index. | in implantation window period(12-14 days) |
| clinical pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Li | Contact | +8613548550909 | 51261886@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiming Wang, Dr | Navy General Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Navy General Hospital. | Recruiting | Beijing | Beijing Municipality | 100048 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22885017 | Background | 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. | |
| 23063812 | Background | 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. |
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The standards is to detect fetal heart beat by ultrasound. |
| an expected average of 7 week after pregnancy |
| live birth rate | The statistical ratio of live birth rate in two groups | follow-up for one year after pregnancy |
| the rate of birth defects | calculate the rate of birth defects in two groups | follow-up for one year after pregnancy |
| the expression changes of endometrial inflammatory factors | Detection of inflammatory factors, such as LIF,MIP-1. --------------------------- | endometrial sampling after local injury ,in the first 3-5 days after menstrual period |
| infection rate | detection of infection by serum test | one week after intervention |
| 17681303 | Background | 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. |
| 5050152 | Result | 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. |
| 20607003 | Result | 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. |
| 12798877 | Result | 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. |
| 19568761 | Result | 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. |
| 22943664 | Result | 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. |
| 24639710 | Result | 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. |
| 20338560 | Result | 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. |