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Endometrial Local Injury to Improve the Outcome of Embryo Transfer

Primary Purpose

Female Infertility Due to Nonimplantation of Ovum

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endometrial local injury
Sponsored by
Navy General Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Infertility Due to Nonimplantation of Ovum focused on measuring endometrial local injury, repeated implatation failure, embyo transfer

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology, Navy General Hospital.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endometrial local injury

The blank group

Arm Description

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

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

Outcomes

Primary Outcome Measures

implantation rate
When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.

Secondary Outcome Measures

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.
clinical pregnancy rate
The standards is to detect fetal heart beat by ultrasound.
live birth rate
The statistical ratio of live birth rate in two groups
the rate of birth defects
calculate the rate of birth defects in two groups
the expression changes of endometrial inflammatory factors
Detection of inflammatory factors, such as LIF,MIP-1. ---------------------------
infection rate
detection of infection by serum test

Full Information

First Posted
November 22, 2014
Last Updated
January 4, 2016
Sponsor
Navy General Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02306395
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility Due to Nonimplantation of Ovum
Keywords
endometrial local injury, repeated implatation failure, embyo transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endometrial local injury
Arm Type
Experimental
Arm Description
Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.
Arm Title
The blank group
Arm Type
No Intervention
Arm Description
Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy.
Intervention Type
Procedure
Intervention Name(s)
Endometrial local injury
Intervention Description
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.
Primary Outcome Measure Information:
Title
implantation rate
Description
When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
the change of three-dimensional ultrasound of uterine cavity before and after intervention
Description
including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index.
Time Frame
in implantation window period(12-14 days)
Title
clinical pregnancy rate
Description
The standards is to detect fetal heart beat by ultrasound.
Time Frame
an expected average of 7 week after pregnancy
Title
live birth rate
Description
The statistical ratio of live birth rate in two groups
Time Frame
follow-up for one year after pregnancy
Title
the rate of birth defects
Description
calculate the rate of birth defects in two groups
Time Frame
follow-up for one year after pregnancy
Title
the expression changes of endometrial inflammatory factors
Description
Detection of inflammatory factors, such as LIF,MIP-1. ---------------------------
Time Frame
endometrial sampling after local injury ,in the first 3-5 days after menstrual period
Title
infection rate
Description
detection of infection by serum test
Time Frame
one week after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Li
Phone
+8613548550909
Email
51261886@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiming Wang, Dr
Organizational Affiliation
Navy General Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Navy General Hospital.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhai Chuai, Dr
Phone
+8618810892004
Email
wangyh85@foxmail.com
First Name & Middle Initial & Last Name & Degree
Aiming Wang, Dr
Phone
+8618600310258
Email
one_army@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22885017
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.
Results Reference
background
PubMed Identifier
23063812
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.
Results Reference
background
PubMed Identifier
17681303
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.
Results Reference
background
PubMed Identifier
5050152
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.
Results Reference
result
PubMed Identifier
20607003
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.
Results Reference
result
PubMed Identifier
12798877
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.
Results Reference
result
PubMed Identifier
19568761
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.
Results Reference
result
PubMed Identifier
22943664
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.
Results Reference
result
PubMed Identifier
24639710
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.
Results Reference
result
PubMed Identifier
20338560
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.
Results Reference
result

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Endometrial Local Injury to Improve the Outcome of Embryo Transfer

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