Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
NCT ID: NCT01798862
Last Updated: 2016-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2013-03-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endometrial injury by hysteroscopy or pipelle sapling
Endometrial Sampling by pipelle or hysteroscopy performed once between 6th to 10th day in the cycle prior to the fresh IVF/ ICSI cycle.
Endometrial injury by hysteroscopy or pipelle sampling
COH for IVF without hysteroscopy or pipelle sampling
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.
Proceed to COH directly
Interventions
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Endometrial injury by hysteroscopy or pipelle sampling
Proceed to COH directly
Eligibility Criteria
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Inclusion Criteria
* Age\</= 42 years
* Good response with good quality embryos in previous attempts (\>2)
Exclusion Criteria
* Sonographically detected hydrosalpinges
* Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
* Thrombophilia
25 Years
42 Years
FEMALE
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Siristatidis Charalampos, MD, PhD
Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction
Principal Investigators
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Maria Kreatsa, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens
Charalampos Siristatidis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Kapodistrian University of Athens
Locations
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Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
Athens, Attica, Greece
Assisted Reproduction Unit
Alexandroupoli, Thrace, Greece
Countries
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References
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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.
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.
Other Identifiers
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121212
Identifier Type: -
Identifier Source: org_study_id
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