The Effectiveness of Endometrial Injury in IVF
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 21, 2015
April 1, 2015
10 months
January 6, 2015
April 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
See heart beat with ultrasonic exam.
35 days after embryo transfer
Secondary Outcomes (1)
Ectopic pregnancy rate
35 days after embryo transfer
Study Arms (4)
Young age group-Luteal phase
EXPERIMENTALEndometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Young age group-Early follicular phase
ACTIVE COMPARATOREndometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Advanced age group-Luteal phase
EXPERIMENTALEndometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer.
Advanced age group-Early follicular phase
ACTIVE COMPARATOREndometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer.
Interventions
local injury to the endometrium by Pipelle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Related Publications (5)
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.
PMID: 25205759BACKGROUNDNastri 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.
PMID: 25803542BACKGROUNDPotdar 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: 23063812BACKGROUNDEl-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: 22885017BACKGROUNDDain 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.
PMID: 25064410BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yingpu Sun, MD,PhD
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Reproductive Medical Center
Study Record Dates
First Submitted
January 6, 2015
First Posted
April 7, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
April 21, 2015
Record last verified: 2015-04