Clinical trial NCT02306395: Endometrial Local Injury to Improve the Outcome of Embryo Transfer
Official title: Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Infertility Due to Nonimplantation of Ovum
Keywords: endometrial local injury
repeated implatation failure
embyo transfer
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: implantation rate
timeFrame: 3 months after intervention
Secondary outcomes:
measure: the change of three-dimensional ultrasound of uterine cavity before and after intervention
timeFrame: in implantation window period(12-14 days)
measure: clinical pregnancy rate
timeFrame: an expected average of 7 week after pregnancy
measure: live birth rate
timeFrame: follow-up for one year after pregnancy
measure: the rate of birth defects
timeFrame: follow-up for one year after pregnancy
measure: the expression changes of endometrial inflammatory factors
timeFrame: endometrial sampling after local injury ,in the first 3-5 days after menstrual period
measure: infection rate
timeFrame: one week after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, Navy General Hospital.
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Aiming Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.