NCT02306395

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2.9 years

First QC Date

November 22, 2014

Last Update Submit

January 4, 2016

Conditions

Female Infertility Due to Nonimplantation of Ovum

Keywords

endometrial local injuryrepeated implatation failureembyo transfer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • the change of three-dimensional ultrasound of uterine cavity before and after intervention

    in implantation window period(12-14 days)

  • clinical pregnancy rate

    an expected average of 7 week after pregnancy

  • live birth rate

    follow-up for one year after pregnancy

  • the rate of birth defects

    follow-up for one year after pregnancy

  • the expression changes of endometrial inflammatory factors

    endometrial sampling after local injury ,in the first 3-5 days after menstrual period

  • +1 more secondary outcomes

Study Arms (2)

Endometrial local injury

EXPERIMENTAL

Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.

Procedure: Endometrial local injury

The blank group

NO INTERVENTION

Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy.

Interventions

Endometrial local injuryPROCEDURE

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.

Endometrial local injury

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Navy General Hospital.

Beijing, Beijing Municipality, 100048, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 22885017BACKGROUND

  • 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.

    PMID: 23063812BACKGROUND

  • 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.

    PMID: 17681303BACKGROUND

  • 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.

    PMID: 5050152RESULT

  • 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.

    PMID: 20607003RESULT

  • 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.

    PMID: 12798877RESULT

  • 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.

    PMID: 19568761RESULT

  • 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.

    PMID: 22943664RESULT

  • 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.

    PMID: 24639710RESULT

  • 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.

    PMID: 20338560RESULT

Study Officials

  • Aiming Wang, Dr

    Navy General Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Li

CONTACT

+861354855090951261886@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Study Record Dates

First Submitted

November 22, 2014

First Posted

December 3, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

CN(1)