The Effectiveness of Endometrial Injury in IVF

NCT ID: NCT02409745

Last Updated: 2015-04-21

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate in patients undergoing in vitro fertilization and embryo transfer. However, only a limited number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase in the previous cycle; 2)early follicular phase in the current cycle. However, few studies have compared the effectiveness of those two different endometrial scratch methods performed in different timing. The aim of this study is to find the best timing of endometrial scratch in FET cycles.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Young age group-Luteal phase

Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.

Group Type EXPERIMENTAL

endometrial scratch

Intervention Type PROCEDURE

local injury to the endometrium by Pipelle

Young age group-Early follicular phase

Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.

Group Type ACTIVE_COMPARATOR

endometrial scratch

Intervention Type PROCEDURE

local injury to the endometrium by Pipelle

Advanced age group-Luteal phase

Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.

Group Type EXPERIMENTAL

endometrial scratch

Intervention Type PROCEDURE

local injury to the endometrium by Pipelle

Advanced age group-Early follicular phase

Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.

Group Type ACTIVE_COMPARATOR

endometrial scratch

Intervention Type PROCEDURE

local injury to the endometrium by Pipelle

Interventions

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endometrial scratch

local injury to the endometrium by Pipelle

Intervention Type PROCEDURE

Other Intervention Names

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endometrial injury

Eligibility Criteria

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Inclusion Criteria

* To be aged younger than 40 years old;
* At least one period IVF-ET (fresh or thaw) has been done and not pregnant after at least one qualified blastocyst (more than 3BB) or two qualified embryos (more than II/6) have been transferred;
* There are qualified embryos thawed and the thaw-ET period will be taken.

Exclusion Criteria

* Malformation of uterus: such as uterus uni-corns, uterus bi-corns, untreated uterus septus, etc.;
* History of endometrial diseases: such as intrauterine adhesion, uterine cavity tuberculosis, severe dysplasia of endometrium, etc.;
* Multiple myomata or endometrioma which causes uterus oppression;
* Multiple and recurrent endometrial polyps;
* Pelvic tuberculosis, endometriosis.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Yingpu Sun

Director of Reproductive Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yingpu Sun, MD,PhD

Role: STUDY_CHAIR

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Locations

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Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingpu Sun, MD,PhD

Role: CONTACT

86-13803841888

Linli Hu, MD,PhD

Role: CONTACT

86-15890619576

Facility Contacts

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Yang Wang, M.D

Role: primary

References

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Yeung TW, Chai J, Li RH, Lee VC, Ho PC, Ng EH. The effect of endometrial injury on ongoing pregnancy rate in unselected subfertile women undergoing in vitro fertilization: a randomized controlled trial. Hum Reprod. 2014 Nov;29(11):2474-81. doi: 10.1093/humrep/deu213. Epub 2014 Sep 8.

Reference Type BACKGROUND
PMID: 25205759 (View on PubMed)

Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3.

Reference Type BACKGROUND
PMID: 25803542 (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)

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)

Dain L, Ojha K, Bider D, Levron J, Zinchenko V, Walster S, Dirnfeld M. Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles. Fertil Steril. 2014 Oct;102(4):1048-54. doi: 10.1016/j.fertnstert.2014.06.044. Epub 2014 Jul 23.

Reference Type BACKGROUND
PMID: 25064410 (View on PubMed)

Other Identifiers

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RMCZZU-EEI

Identifier Type: -

Identifier Source: org_study_id

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