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The Effectiveness of Endometrial Injury in IVF

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endometrial scratch
Sponsored by
The First Affiliated Hospital of Zhengzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring endometrial scratch, IVF, randomized controlled study, Prospective controlled trial, Different time to perform endometrial scratch, In vitro fertilization, embryo transfer

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Young age group-Luteal phase

Young age group-Early follicular phase

Advanced age group-Luteal phase

Advanced age group-Early follicular phase

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
See heart beat with ultrasonic exam.

Secondary Outcome Measures

Ectopic pregnancy rate
No sac can be seen inside uterine 35 days after embryo transfer, but with high hCG level

Full Information

First Posted
January 6, 2015
Last Updated
April 18, 2015
Sponsor
The First Affiliated Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT02409745
Brief Title
The Effectiveness of Endometrial Injury in IVF
Official Title
The Effectiveness of Endometrial Injury in Different Phase of Menstrual Cycle:a Prospective Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
endometrial scratch, IVF, randomized controlled study, Prospective controlled trial, Different time to perform endometrial scratch, In vitro fertilization, embryo transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young age group-Luteal phase
Arm Type
Experimental
Arm Description
Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Arm Title
Young age group-Early follicular phase
Arm Type
Active Comparator
Arm Description
Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Arm Title
Advanced age group-Luteal phase
Arm Type
Experimental
Arm Description
Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Arm Title
Advanced age group-Early follicular phase
Arm Type
Active Comparator
Arm Description
Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Intervention Type
Procedure
Intervention Name(s)
endometrial scratch
Other Intervention Name(s)
endometrial injury
Intervention Description
local injury to the endometrium by Pipelle
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
See heart beat with ultrasonic exam.
Time Frame
35 days after embryo transfer
Secondary Outcome Measure Information:
Title
Ectopic pregnancy rate
Description
No sac can be seen inside uterine 35 days after embryo transfer, but with high hCG level
Time Frame
35 days after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingpu Sun, MD,PhD
Phone
86-13803841888
Email
syp2008@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linli Hu, MD,PhD
Phone
86-15890619576
Email
hulinli1999@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingpu Sun, MD,PhD
Organizational Affiliation
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Wang, M.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
25205759
Citation
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.
Results Reference
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PubMed Identifier
25803542
Citation
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.
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
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
25064410
Citation
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.
Results Reference
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The Effectiveness of Endometrial Injury in IVF

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