Antimullerian Hormone in Endometriomas

Endometriomas Clinical Trial

Official title:

Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery. A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669628
• Other study ID #: PR314/15
• Status: Completed
• Phase: N/A
• First received: January 23, 2016
• Last updated: February 21, 2018
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

Description:

Between 5-10% fertile women are affected by endometriosis, and ovarian endometrioma is present in 17-44% of cases, with 40% of patients with endometriomas being sterile. However, the "gold standard" treatment is laparoscopic ovarian cystectomy and this therapy is associated with a diminished ovarian reserve, with a significant antimullerian hormone (AMH) decrease.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women

• 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:

• Previous ovarian surgery or gynecological cancer

• Severe extraovarian endometriosis

• Dermoid or high risk of malignancy cysts

• Hormonal treatment 3 months before

• Pregnancy

• Mental disability

Related Conditions & MeSH terms

• Endometriomas
• Endometriosis

Intervention

Procedure:
• Surgical technique
Laparoscopic surgery
• Alcohol sclerotherapy
US-guided sclerotherapy

Locations

Country	Name	City	State
Spain	Hospital Universitario Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Roche Diagnostic Ltd.

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

García-Tejedor A, Castellarnau M, Ponce J, Fernández 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. — View Citation

Kafali H, Eser A, Duvan CI, Keskin E, Onaran YA. Recurrence of ovarian cyst after sclerotherapy. Minerva Ginecol. 2011 Feb;63(1):19-24. — View Citation

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. — View Citation

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. — View Citation

Muzii L, Bianchi A, Crocè 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. — View Citation

Noma J, Yoshida N. Efficacy of ethanol sclerotherapy for ovarian endometriomas. Int J Gynaecol Obstet. 2001 Jan;72(1):35-9. — View Citation

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. Review. — View Citation

Somigliana E, Berlanda N, Benaglia L, Viganò P, Vercellini P, Fedele L. Surgical excision of endometriomas and ovarian reserve: a systematic review on serum antimüllerian hormone level modifications. Fertil Steril. 2012 Dec;98(6):1531-8. doi: 10.1016/j.fertnstert.2012.08.009. Epub 2012 Sep 10. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH Test	the value of AMH after both procedures in ng/mL	6 months
Secondary	antral follicles count	US antral follicles count after both procedures	6 months
Secondary	tumoral markers: epididimal human protein 4 (HE-4) and CA125	the value tumoral markers after both procedures	6 months
Secondary	complications	number of participants with complications	1 day
Secondary	costs	costs (euros) of the procedures and their complications	1 day