NCT01798862|CompletedPhase 2/3
Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
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The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures
Sponsor study identifier
interventional
100
1 country
2
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2013
Actual (reported)February 26, 2013
Actual (reported)March 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 2016
Actual (reported)June 2016
Actual (reported)positive bHCG rate
through study completion, an average of 2 years
clinical pregnancy rate
2 years
live birth rate
2 years
Ectopic pregnancy rate
2 years
Miscarriage rate
2 years
Ongoing pregnancy rate
2 years
Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.
Procedure: COH for IVF Both GnRH agonists (long, starting at day 2 or 21) with triptorelin acetate 0.1 mg (Gonapeptyl daily) and antagonists with ganirelix 0.25mg (Orgalutran) or cetrorelix 0.25mg (Cetrotide) protocols will be used; for ovarian stimulation both recombinant FSH ( Puregon) and human menopausal gonadotrophin ( Menopur) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the Hcg triggering and for luteal phase support 600 mg progesterone tablets ( Utrogestan) will be applied.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
Athens, Attica, 12642, Greece
Assisted Reproduction Unit
Alexandroupoli, Thrace, Greece
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.
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.
Maria Kreatsa, MD/PhD
National and Kapodistrian University of Athens
Charalampos Siristatidis, MD, PhD
National and Kapodistrian University of Athens
100 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2013
First Posted
February 26, 2013
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
May 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
June 10, 2016
Record last verified: 2016-06
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Source: ClinicalTrials.gov.
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