Clinical trial NCT02409745: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: endometrial scratch
IVF
randomized controlled study
Prospective controlled trial
Different time to perform endometrial scratch
In vitro fertilization
embryo transfer
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 35 days after embryo transfer
Secondary outcomes:
measure: Ectopic pregnancy rate
timeFrame: 35 days after embryo transfer
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
name: Yingpu Sun, MD,PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.