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EndometriomaNCT03571776

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

A study testing Surgery and Sclerotherapy in people with Endometrioma and Fertility Disorders, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometrioma, Fertility Disorders
What is being tested?
Surgery and Sclerotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteSpain
Study dates
5 Jun 2018to 15 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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,

Who cannot join

  • Previous gynecological cancer
  • Symptomatic severe extraovarian endometriosis
  • Dermoid or high risk of malignancy cysts
  • Pregnancy
  • Mental disability

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Surgery, Sclerotherapy
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Laparoscopic ovarian cystectomy

  • SclerotherapyProcedure or surgery

    US-aspiration and alcohol sclerosis

Study groups in NCT03571776
Study groupRoleWhat they receive
SurgeryActive comparatorLaparoscopic ovarian cystectomy
Receives: Procedure: Surgery
SclerotherapyActive comparatorUS-aspiration and alcohol sclerosis
Receives: Procedure: Sclerotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline AMH Test

    the value of AMH in ng/mL

    Measured: prior and 6 months after both procedures

Secondary outcomes (4)

  1. Change from Baseline antral follicles count

    US antral follicles count

    Measured: prior and 6 months after both procedures

  2. Complications

    number of participants with complications

    Measured: 1 month after the procedure

  3. Costs

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

    Measured: 1 month after the procedure

  4. Change from Baseline Pain

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

    Measured: prior and 6 months after both procedures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start5 Jun 2018
  3. Primary completion15 Jan 2023
  4. Study completion15 Jan 2023

Why it stopped: Low recruitment because patients and gynecologists prefer the sclerosis arm to avoid surgery

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571776
Sponsor's protocol ID
PR031/18
Status last verified
Feb 2023
First submitted
31 May 2018
Last updated
2 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18243485

  • 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.

    PubMed 11872220

  • 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.

    PubMed 3283269

  • 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.

    PubMed 11146075

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

    PubMed 21311417

  • 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.

    PubMed 22723324

  • 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.

    PubMed 22019621

  • 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.

    PubMed 19573300

  • 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.

    PubMed 25739052

  • 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.

    PubMed 22975114

  • Garcia-Tejedor A, Guevara-Peralta R, Martinez-Garcia JM, Corbalan S, Aguero M, Gomez-Romero M, Cararach M, Castellarnau M, Rodriguez M, Lou-Mercade AC, Costa L, Rodriguez MJ, Huguet E, Carreras M, Castel-Segui AB, Font-Roig M, Royo S, Sarasa N, Candas B, Perez-Carton S, Ortega C, Pla MJ, Ponce J. Ultrasound-guided ethanol sclerotherapy versus laparoscopic surgery for endometriomas: a randomized clinical trial in a real-world setting. Arch Gynecol Obstet. 2025 Dec;312(6):2199-2210. doi: 10.1007/s00404-025-08205-1. Epub 2025 Nov 4.

    PubMed 41186685

Questions about this trial

What is this clinical trial studying?

A study testing Surgery and Sclerotherapy in people with Endometrioma and Fertility Disorders, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low recruitment because patients and gynecologists prefer the sclerosis arm to avoid surgery). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline AMH Test (time frame: prior and 6 months after both procedures). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03571776, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.

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