Study Results
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Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2016-02-29
2018-01-31
Brief Summary
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Detailed Description
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Alcohol sclerotherapy is a new minimal invasive procedure in endometrioma treatment whose potential beneficial effect in fertility preservation is not still demonstrated.
The investigators would like to demonstrate that this procedure improves fertility preservation and reduces morbidity and costs in contrast with conventional surgery. Moreover,the investigators would like to demonstrate that this procedure could be performed in different centers with similar results.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical technique
Laparoscopic ovarian cystectomy
Surgical technique
Laparoscopic surgery
Alcohol sclerotherapy
US-aspiration and alcohol sclerosis
Alcohol sclerotherapy
US-guided sclerotherapy
Interventions
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Surgical technique
Laparoscopic surgery
Alcohol sclerotherapy
US-guided sclerotherapy
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 and \<40 years
* Unilocular endometrioma according ultrasounds
* Endometrioma size: 35-100 mm during \> 3 months from diagnosis
* CA125 \<200 IU/mL and HE4 \< 70,
* AMH previous surgery between 1.2-4 ng/mL
Exclusion Criteria
* Severe extraovarian endometriosis
* Dermoid or high risk of malignancy cysts
* Hormonal treatment 3 months before
* Pregnancy
* Mental disability
18 Years
40 Years
FEMALE
No
Sponsors
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Roche Diagnostic Ltd.
INDUSTRY
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Amparo Garcia-Tejedor
Dr
Principal Investigators
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Amparo Garcia-Tejedor, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Bellvitge. IDIBELL
Locations
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Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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Coccia ME, Rizzello F, Cammilli F, Bracco GL, Scarselli G. Endometriosis and infertility Surgery and ART: An integrated approach for successful management. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):54-9. doi: 10.1016/j.ejogrb.2007.11.010. Epub 2008 Feb 20.
Muzii L, Bianchi A, Croce C, Manci N, Panici PB. Laparoscopic excision of ovarian cysts: is the stripping technique a tissue-sparing procedure? Fertil Steril. 2002 Mar;77(3):609-14. doi: 10.1016/s0015-0282(01)03203-4.
Raffi F, Metwally M, Amer S. The impact of excision of ovarian endometrioma on ovarian reserve: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012 Sep;97(9):3146-54. doi: 10.1210/jc.2012-1558. Epub 2012 Jun 20.
Biacchiardi CP, Piane LD, Camanni M, Deltetto F, Delpiano EM, Marchino GL, Gennarelli G, Revelli A. Laparoscopic stripping of endometriomas negatively affects ovarian follicular reserve even if performed by experienced surgeons. Reprod Biomed Online. 2011 Dec;23(6):740-6. doi: 10.1016/j.rbmo.2011.07.014. Epub 2011 Jul 27.
Akamatsu N, Hirai T, Masaoka H, Sekiba K, Fujita T. [Ultrasonically guided puncture of endometrial cysts--aspiration of contents and infusion of ethanol]. Nihon Sanka Fujinka Gakkai Zasshi. 1988 Feb;40(2):187-91. Japanese.
Noma J, Yoshida N. Efficacy of ethanol sclerotherapy for ovarian endometriomas. Int J Gynaecol Obstet. 2001 Jan;72(1):35-9. doi: 10.1016/s0020-7292(00)00307-6.
Messalli EM, Cobellis G, Pecori E, Pierno G, Scaffa C, Stradella L, Cobellis L. Alcohol sclerosis of endometriomas after ultrasound-guided aspiration. Minerva Ginecol. 2003 Aug;55(4):359-62.
Kafali H, Eser A, Duvan CI, Keskin E, Onaran YA. Recurrence of ovarian cyst after sclerotherapy. Minerva Ginecol. 2011 Feb;63(1):19-24.
Yazbeck C, Madelenat P, Ayel JP, Jacquesson L, Bontoux LM, Solal P, Hazout A. Ethanol sclerotherapy: a treatment option for ovarian endometriomas before ovarian stimulation. Reprod Biomed Online. 2009 Jul;19(1):121-5. doi: 10.1016/s1472-6483(10)60055-7.
Garcia-Tejedor A, Castellarnau M, Ponce J, Fernandez ME, Burdio F. Ethanol sclerotherapy of ovarian endometrioma: a safe and effective minimal invasive procedure. Preliminary results. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:25-9. doi: 10.1016/j.ejogrb.2015.02.004. Epub 2015 Feb 16.
Somigliana E, Berlanda N, Benaglia L, Vigano P, Vercellini P, Fedele L. Surgical excision of endometriomas and ovarian reserve: a systematic review on serum antimullerian hormone level modifications. Fertil Steril. 2012 Dec;98(6):1531-8. doi: 10.1016/j.fertnstert.2012.08.009. Epub 2012 Sep 10.
Koike T, Minakami H, Motoyama M, Ogawa S, Fujiwara H, Sato I. Reproductive performance after ultrasound-guided transvaginal ethanol sclerotherapy for ovarian endometriotic cysts. Eur J Obstet Gynecol Reprod Biol. 2002 Oct 10;105(1):39. doi: 10.1016/s0301-2115(02)00144-6.
Other Identifiers
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PR314/15
Identifier Type: -
Identifier Source: org_study_id
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