Endometrial Local Injury to Improve the Outcome of Embryo Transfer

Female Infertility Due to Nonimplantation of Ovum Clinical Trial

Official title:

Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306395
• Other study ID #: LY-2014
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2014
• Last updated: January 4, 2016
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: Navy General Hospital, Beijing
• Contact: Yi Li
• Phone: +8613548550909
• Email: 51261886[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Infertility Due to Nonimplantation of Ovum
• Infertility, Female

Intervention

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.

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, Navy General Hospital.	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. d — View 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. Review. — View 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. — View 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.2010.02.02 — View 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):499-5 — View 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 — View 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. — View 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. Review. — View 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):1166-76. Epub 2007 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	Yes
Secondary	clinical pregnancy rate	The standards is to detect fetal heart beat by ultrasound.	an expected average of 7 week after pregnancy	Yes
Secondary	live birth rate	The statistical ratio of live birth rate in two groups	follow-up for one year after pregnancy	Yes
Secondary	the rate of birth defects	calculate the rate of birth defects in two groups	follow-up for one year after pregnancy	Yes
Secondary	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	Yes
Secondary	infection rate	detection of infection by serum test	one week after intervention	Yes