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

Primary Purpose

Endometrioma, Fertility Disorders

Status

Terminated

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Surgery

Sclerotherapy

About this trial

This is an interventional treatment trial for Endometrioma

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Surgery

Sclerotherapy

Arm Description

Laparoscopic ovarian cystectomy

US-aspiration and alcohol sclerosis

Outcomes

Primary Outcome Measures

Change from Baseline AMH Test

the value of AMH in ng/mL

Secondary Outcome Measures

Change from Baseline antral follicles count

US antral follicles count

Complications

number of participants with complications

Costs

costs (euros) of the procedure plus cost of their complications

Change from Baseline Pain

Visual Analog Score for pain (ranged 1-10). Patients pain evaluation fron 1 no pain to 10 maximum pain considered

Full Information

NCT ID

NCT03571776

First Posted

May 31, 2018

Last Updated

February 28, 2023

Sponsor

Hospital Universitari de Bellvitge

1. Study Identification

Unique Protocol Identification Number

NCT03571776

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment because patients and gynecologists prefer the sclerosis arm to avoid surgery

Study Start Date

June 5, 2018 (Actual)

Primary Completion Date

January 15, 2023 (Actual)

Study Completion Date

January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitari de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrioma, Fertility Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

158 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Active Comparator

Arm Description

Laparoscopic ovarian cystectomy

Arm Title

Sclerotherapy

Arm Type

Active Comparator

Arm Description

US-aspiration and alcohol sclerosis

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Laparoscopic ovarian cystectomy

Intervention Type

Procedure

Intervention Name(s)

Sclerotherapy

Intervention Description

US-aspiration and alcohol sclerosis

Primary Outcome Measure Information:

Title

Change from Baseline AMH Test

Description

the value of AMH in ng/mL

Time Frame

prior and 6 months after both procedures

Secondary Outcome Measure Information:

Title

Change from Baseline antral follicles count

Description

US antral follicles count

Time Frame

prior and 6 months after both procedures

Title

Complications

Description

number of participants with complications

Time Frame

1 month after the procedure

Title

Costs

Description

costs (euros) of the procedure plus cost of their complications

Time Frame

1 month after the procedure

Title

Change from Baseline Pain

Description

Visual Analog Score for pain (ranged 1-10). Patients pain evaluation fron 1 no pain to 10 maximum pain considered

Time Frame

prior and 6 months after both procedures

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amparo Garcia-Tejedor, MDPhD

Organizational Affiliation

Hospital de Bellvitge. IDIBELL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18243485

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.

Results Reference

background

PubMed Identifier

11872220

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.

Results Reference

background

PubMed Identifier

3283269

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.

Results Reference

background

PubMed Identifier

11146075

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.

Results Reference

background

PubMed Identifier

21311417

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.

Results Reference

background

PubMed Identifier

22723324

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.

Results Reference

result

PubMed Identifier

22019621

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.

Results Reference

result

PubMed Identifier

19573300

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.

Results Reference

result

PubMed Identifier

25739052

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.

Results Reference

result

PubMed Identifier

22975114

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.

Results Reference

result

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

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