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
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2013
Typical duration for phase_2
2 active sites
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
February 19, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 10, 2016
June 1, 2016
3.2 years
February 19, 2013
June 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
positive bHCG rate
through study completion, an average of 2 years
Secondary Outcomes (6)
clinical pregnancy rate
2 years
live birth rate
2 years
Ectopic pregnancy rate
2 years
Miscarriage rate
2 years
Ongoing pregnancy rate
2 years
- +1 more secondary outcomes
Study Arms (2)
Endometrial injury by hysteroscopy or pipelle sapling
EXPERIMENTALEndometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.
COH for IVF without hysteroscopy or pipelle sampling
ACTIVE COMPARATORProcedure: 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.
Interventions
Eligibility Criteria
You may qualify if:
- Personal history of 2 or more failed IVF/ICSI cycles (RIF)
- Age\</= 42 years
- Good response with good quality embryos in previous attempts (\>2)
You may not qualify if:
- Personal history of endometrial tuberculosis/ antituberculous treatment
- Sonographically detected hydrosalpinges
- Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
- Thrombophilia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
Athens, Attica, 12642, Greece
Assisted Reproduction Unit
Alexandroupoli, Thrace, Greece
Related Publications (5)
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: 22943664BACKGROUNDKarimzadeh 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: 20070722RESULTNarvekar 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: 20607003RESULTEl-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: 22885017RESULTPotdar 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: 23063812RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Kreatsa, MD/PhD
National and Kapodistrian University of Athens
- PRINCIPAL INVESTIGATOR
Charalampos Siristatidis, MD, PhD
National Kapodistrian University of Athens
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction
Study Record Dates
First Submitted
February 19, 2013
First Posted
February 26, 2013
Study Start
March 1, 2013
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 10, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will share