PROCEDURE
Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
100
Locations
2
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
PROCEDURE
Proceed to COH directly
Timeline
From registration to results.
First posted
Feb 26, 2013
Study start
Mar 2013
Primary completion
May 2016
Study completion
Jun 2016
Results posted
Not reported
Registry updated
Jun 10, 2016
Outcomes
What the study measures.
Primary outcomes
positive bHCG rate
Time frame · through study completion, an average of 2 years
Secondary outcomes
clinical pregnancy rate
Time frame · 2 years
live birth rate
Time frame · 2 years
Ectopic pregnancy rate
Time frame · 2 years
Miscarriage rate
Time frame · 2 years
Ongoing pregnancy rate
Time frame · 2 years
Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)
Time frame · 2 years
Eligibility
Who can take part.
- Minimum age
- 25 Years
- Maximum age
- 42 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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
Study locations
2 registered sites.
Greece. Showing up to 24 locations stored in the fast local snapshot.
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
Athens, Attica, Greece
Assisted Reproduction Unit
Alexandroupoli, Thrace, Greece
Publications
Results and literature.
PMID 22943664 ↗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.PMID 20070722 ↗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.PMID 20607003 ↗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.PMID 22885017 ↗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.PMID 23063812 ↗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.
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