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EndometriomaNCT05801523

Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans

A study testing laparoscopic ethanol sclerotherapy and laparoscopic cystectomy of endometrioma in people with Endometrioma and Endometriosis, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometrioma, Endometriosis
What is being tested?
laparoscopic ethanol sclerotherapy and laparoscopic cystectomy of endometrioma
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteCzechia
Study dates
1 Feb 2023to 1 Jul 2025
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • IOTA benign endometrioma
  • bilateral or unilateral endometrioma measuring 30 or more milimeters
  • patients with unfinished reproductive plans

Who cannot join

  • bilateral recurrence of endometrioma
  • recurrent endometrioma if the other ovary is not present or patient had cystectomy on the other ovary
  • suspision for ovarian malignancy
  • signs of inflammatory pelvic disease
  • disagreement with participation in the study

Trial locations and contacts

1 site in 1 country.

Katarína Ivánková contact

+420 296511200

katarina.ivankova@upmd.eu

Czechia1 site, 1 recruiting

  • Institute for mother and child care

    Prague, 147 00

    Katarína Ivánková, MUDr., katarina.ivankova@upmd.eu

    Katarína Ivánková, MUDr.

    Recruiting

Other trials in Czechia

About this study

The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate

Read the detailed description

Only patients who sign informed consent will be included. Only patients wishing for future pregnancy will be involved in the study. Expected number of enrolled subjects is 160 ( 80 in each arm) Patients with endometrioma and planned surgery to remove it will be randomized either to laparoscopic sclerotherapy with 96% ethanol or cystectomy. First AMH sample will be taken day before surgery. If other endometriosis lesions (deep or superficial) are present, they may be also resected during this surgery.

Ethanol sclerotherapy description: classical laparoscopic approach - small (max1cm) fenestration of endometrioma - aspiration of endometrioma contents- foley catheter insertion- ballon inflation inside of the cyst- instillation with 96% ethanol which is left in the cyst for 10min- aspiration of ethanol and flushing with saline.

Cystectomy: classical laparoscopic approach- large fenestration of endometrioma - aspiration of endometrioma contents- indentification of ovary/ endometrioma tissue and plane between the ovarian capsule and cyst wall is developed using a mix of blunt and sharp dissection - if bleeding is present it is stopped by cautious bipolar coagulation

visit 1 - surgery time (AMH day before surgery, age, BMI, endometriosis extent, gravidity/ parity, endometriosis residue after surgery, pain levels) visit 2- 3 months after surgery : Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 3+4 - 6/12months after surgery: AMH, Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 5- 24 months after surgery: Ultrasound, complications, pregnancy, asissted reproduction, pain levels

Being tested
laparoscopic ethanol sclerotherapy, laparoscopic cystectomy of endometrioma
Keywords
laparoscopic, sclerotherapy, endometrioma
Medical subject headings
Endometriosis

What participants receive

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

  • laparoscopic ethanol sclerotherapyProcedure or surgery

    ethanol (96%) sclerapy of endometrioma - endometrioma is filled with ethanol via foley catether, left for 10 min and than aspirated, endometrioma is washed with saline

  • laparoscopic cystectomy of endometriomaProcedure or surgery

    cystectomy of endometrioma - removal of endometrioma from ovary surgically

Study groups in NCT05801523
Study groupRoleWhat they receive
laparoscopic ethanol sclerotherapyActive comparatorNot described
Receives: Procedure: laparoscopic ethanol sclerotherapy
laparoscopic cystectomyActive comparatorNot described
Receives: Procedure: laparoscopic cystectomy of endometrioma

What is being measured

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

  1. AMH dynamics

    Measuring AMH level in blood

    Measured: Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery

  2. endometrioma recurrence

    recurrence described as endometrioma measuring 20 or more milimeters on ultrasound

    Measured: Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery

  3. complications

    recording all complications related to surgery, classified according Clavien Dindo

    Measured: 0-12 months

Secondary outcomes (3)

  1. Asissted reproduction methods succes rate

    if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used

    Measured: 0-24 months after surgery

  2. pregnancy rate

    pregnancy rate among study patients

    Measured: 0-24 months after surgery

  3. deliveries

    number of deliveries after surgery

    Measured: 24 months

Timeline

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

  1. First posted6 Apr 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jul 2025 (estimated)

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
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05801523
Sponsor's protocol ID
AMHstudy
Status last verified
May 2024
First submitted
23 Mar 2023
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.

    PubMed 29420391

  • Busacca M, Vignali M. Ovarian endometriosis: from pathogenesis to surgical treatment. Curr Opin Obstet Gynecol. 2003 Aug;15(4):321-6. doi: 10.1097/01.gco.0000084247.09900.4f.

    PubMed 12858105

  • Cohen A, Almog B, Tulandi T. Sclerotherapy in the management of ovarian endometrioma: systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):117-124.e5. doi: 10.1016/j.fertnstert.2017.05.015. Epub 2017 Jun 1.

    PubMed 28579409

  • Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.

    PubMed 29935810

  • Crestani A, Merlot B, Dennis T, Chanavaz-Lacheray I, Roman H. Impact of Laparoscopic Sclerotherapy for Ovarian Endometriomas on Ovarian Reserve. J Minim Invasive Gynecol. 2023 Jan;30(1):32-38. doi: 10.1016/j.jmig.2022.10.001. Epub 2022 Oct 10.

    PubMed 36228863

  • De Cicco Nardone A, Carfagna P, De Cicco Nardone C, Scambia G, Marana R, De Cicco Nardone F. Laparoscopic Ethanol Sclerotherapy for Ovarian Endometriomas: Preliminary Results. J Minim Invasive Gynecol. 2020 Sep-Oct;27(6):1331-1336. doi: 10.1016/j.jmig.2019.09.792. Epub 2020 May 5.

    PubMed 32380241

  • Benaglia L, Somigliana E, Vercellini P, Abbiati A, Ragni G, Fedele L. Endometriotic ovarian cysts negatively affect the rate of spontaneous ovulation. Hum Reprod. 2009 Sep;24(9):2183-6. doi: 10.1093/humrep/dep202. Epub 2009 Jun 5.

    PubMed 19502358

  • Benaglia L, Somigliana E, Vighi V, Ragni G, Vercellini P, Fedele L. Rate of severe ovarian damage following surgery for endometriomas. Hum Reprod. 2010 Mar;25(3):678-82. doi: 10.1093/humrep/dep464. Epub 2010 Jan 17.

    PubMed 20083485

  • Jee BC. Efficacy of ablation and sclerotherapy for the management of ovarian endometrioma: A narrative review. Clin Exp Reprod Med. 2022 Jun;49(2):76-86. doi: 10.5653/cerm.2021.05183. Epub 2022 May 4.

    PubMed 35698769

  • Giampaolino P, Bifulco G, Di Spiezio Sardo A, Mercorio A, Bruzzese D, Di Carlo C. Endometrioma size is a relevant factor in selection of the most appropriate surgical technique: a prospective randomized preliminary study. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:88-93. doi: 10.1016/j.ejogrb.2015.09.046. Epub 2015 Oct 24.

    PubMed 26492167

  • Garcia-Tejedor A, Martinez-Garcia JM, Candas B, Suarez E, Manalich L, Gomez M, Merino E, Castellarnau M, Regueiro P, Carreras M, Martinez-Franco E, Carrarrach M, Subirats N, Barbera J, Gonzalez S, Climent M, Fernandez-Montoli E, Ponce J. Ethanol Sclerotherapy versus Laparoscopic Surgery for Endometrioma Treatment: A Prospective, Multicenter, Cohort Pilot Study. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1133-1140. doi: 10.1016/j.jmig.2019.08.036. Epub 2020 Apr 7.

    PubMed 32272240

  • Aflatoonian A, Tabibnejad N. Aspiration versus retention ultrasound-guided ethanol sclerotherapy for treating endometrioma: A retrospective cross-sectional study. Int J Reprod Biomed. 2020 Nov 22;18(11):935-942. doi: 10.18502/ijrm.v13i11.7960. eCollection 2020 Nov.

    PubMed 33349801

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic ethanol sclerotherapy and laparoscopic cystectomy of endometrioma in people with Endometrioma and Endometriosis, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.

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 3 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 Czechia. 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?

Results are not available in the source record.

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

Contact Katarína Ivánková (+420 296511200, katarina.ivankova@upmd.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AMH dynamics (time frame: Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery). The study lists 3 primary outcomes in all. 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 NCT05801523, which also lists 12 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 8 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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