Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial

Fertility Disorders Clinical Trial

Official title:

Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03571776
• Other study ID #: PR031/18
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: January 15, 2023

Study information

• Verified date: February 2023
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery (AMH, follicle stimulating hormone (FSH) and antral follicles count) as well as the complications and costs between the 2 procedures.

Description:

Clinical Trial Phase III, Multicenter, National, open, parallel-group assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement. Patients with suspected ovarian endometrioma by ultrasound will be randomized into 2 groups: (a) Study Group: echoguided aspiration plus sclerosis with alcohol; (B) Control group: Laparoscopic Cystectomy. Pre-treatment, and 6 months after treatment, AMH values will be determined. Complications, recurrences and costs from each treatment will be collected.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Uni- or bilocular endometrioma according ultrasounds

• Endometrioma size: 30-100 mm when symptoms were present and 50-100 mm if asymptomatics

• > 3 months from diagnosis

• Ca125 <200 IU/mL and human epididymis protein 4 (HE4) < 70,

Exclusion Criteria:

• Previous gynecological cancer

• Symptomatic severe extraovarian endometriosis

• Dermoid or high risk of malignancy cysts

• Pregnancy

• Mental disability

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Fertility Disorders

Intervention

Procedure:
• Surgery
Laparoscopic ovarian cystectomy
• Sclerotherapy
US-aspiration and alcohol sclerosis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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 — 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

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.ejo — 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

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. — View Citation

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. — 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. — View Citation

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.fe — 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. doi: 10.1016/s1472-6483(10)60055-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline AMH Test	the value of AMH in ng/mL	prior and 6 months after both procedures
Secondary	Change from Baseline antral follicles count	US antral follicles count	prior and 6 months after both procedures
Secondary	Complications	number of participants with complications	1 month after the procedure
Secondary	Costs	costs (euros) of the procedure plus cost of their complications	1 month after the procedure
Secondary	Change from Baseline Pain	Visual Analog Score for pain (ranged 1-10). Patients pain evaluation fron 1 no pain to 10 maximum pain considered	prior and 6 months after both procedures