Clinical trial NCT03571776: Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial
Official title: Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometrioma
Fertility Disorders
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline AMH Test
timeFrame: prior and 6 months after both procedures
Secondary outcomes:
measure: Change from Baseline antral follicles count
timeFrame: prior and 6 months after both procedures
measure: Complications
timeFrame: 1 month after the procedure
measure: Costs
timeFrame: 1 month after the procedure
measure: Change from Baseline Pain
timeFrame: prior and 6 months after both procedures
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital de Bellvitge. IDIBELL
name: Amparo Garcia-Tejedor, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.ejogrb.2015.02.004. Epub 2015 Feb 16.
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.fertnstert.2012.08.009. Epub 2012 Sep 10.