Endometrial Local Injury to Improve the Outcome of Embryo Transfer

NCT ID: NCT02306395

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Female Infertility Due to Nonimplantation of Ovum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endometrial local injury

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

Group Type EXPERIMENTAL

Endometrial local injury

Intervention Type 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.

The blank group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Yunhai Chuai

Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiming Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Locations

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Department of Obstetrics and Gynecology, Navy General Hospital.

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Li

Role: CONTACT

+8613548550909

Facility Contacts

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Yunhai Chuai, Dr

Role: primary

+8618810892004

Aiming Wang, Dr

Role: backup

+8618600310258

References

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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.

Reference Type BACKGROUND
PMID: 22885017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23063812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17681303 (View on PubMed)

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.

Reference Type RESULT
PMID: 5050152 (View on PubMed)

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.

Reference Type RESULT
PMID: 20607003 (View on PubMed)

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.

Reference Type RESULT
PMID: 12798877 (View on PubMed)

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.

Reference Type RESULT
PMID: 19568761 (View on PubMed)

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.

Reference Type RESULT
PMID: 22943664 (View on PubMed)

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.

Reference Type RESULT
PMID: 24639710 (View on PubMed)

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.

Reference Type RESULT
PMID: 20338560 (View on PubMed)

Other Identifiers

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LY-2014

Identifier Type: -

Identifier Source: org_study_id

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