Clinical trial NCT01798862: Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
Official title: The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Repeated Implantation Failures
Keywords: Failed IVF cycles
IVF outcome parameters
endometrial injury
hysteroscopy
pipelle sampling
Repeated implantation failures
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.

Detailed description: Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.

Eligibility criteria: Inclusion Criteria:

* Personal history of 2 or more failed IVF/ICSI cycles (RIF)
* Age\</= 42 years
* Good response with good quality embryos in previous attempts (\>2)

Exclusion Criteria:

* Personal history of endometrial tuberculosis/ antituberculous treatment
* Sonographically detected hydrosalpinges
* Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
* Thrombophilia

Primary outcomes:
measure: positive bHCG rate
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 years
measure: live birth rate
timeFrame: 2 years
measure: Ectopic pregnancy rate
timeFrame: 2 years
measure: Miscarriage rate
timeFrame: 2 years
measure: Ongoing pregnancy rate
timeFrame: 2 years
measure: Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
state: Attica
city: Alexandroupolis
country: Greece
facility: Assisted Reproduction Unit
state: Thrace
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Maria Kreatsa, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Kapodistrian University of Athens
name: Charalampos Siristatidis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
citation: 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.
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: 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.