EndometriomaSTARTNCT05962775
Ethanol Sclerotherapy Prior to ART
A study testing Ethanol Sclerotherapy for Endometrioma in people with Endometrioma and Infertility, run by Ankara University at 3 sites in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are: 1. Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma? 2. 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, Infertility, Sclerotherapy
- What is being tested?
- Ethanol Sclerotherapy for Endometrioma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- AMH>0.3 ng/ml
- unilateral/bilateral endometrioma
- Endometrioma diameter 40-100 mm
Who cannot join
- 3 or more IVF/embryo transfer failure
- Menstrual cycle abnormalities
- Male Factor infertility
- Presence of uterine fibroids
- Presence of hydrosalpinx
- Presence of uterine abnormalities
- Suspicion of malignancy according to International Ovarian Tumor Analysis criteria
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Başkent University Adana IVF Center
Adana
Erhan Şimşek, Assoc. Prof., +90 533 414 62 99, drsimsekerhan@gmail.com
Gülşen Doğan Durdağ
- Recruiting
Ankara University School of Medicine, Department of Obstetrics and Gynecology
Ankara, 06610
Yavuz Emre Şükür, M.D., 00905332409381, yesukur@gmail.com
Batuhan Aslan, M.D., 00905462555335, drbatuhanaslan@gmail.com
- Recruiting
Bahçeci IVF Clinic
Istanbul
Özkan Özdamar, +90 532 476 67 44, ozkan_ozdamar@yahoo.com
Prof
About this study
Official title: The Impact of Ethanol Sclerotherapy Before ART (Assisted Reproductive Technology) Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma: A Randomized Controlled Trial
The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are:
- Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma?
- Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates?
Infertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.
Read the detailed description
The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta-analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes.
Infertile patients aged 18-40 years with at least one endometrioma 4-10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti-mullerian hormone value below 0.3 ng/ml will not be included in the study.
- Conditions
- Endometrioma, Infertility, Sclerotherapy, ART, IVF
- Being tested
- Ethanol Sclerotherapy for Endometrioma
- Keywords
- endometrioma, ethanol sclerotherapy, assisted reproductive technology, in vitro fertilization, cumulative live birth rate
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol Sclerotherapy for EndometriomaProcedure or surgery
2 gr IV cefazolin sodium will be administered 30 minutes before the procedure. The endometrioma cyst content will be aspirated by a single lumen needle, and the total aspirated volume calculation will be done. The endometrioma will then be washed with saline until the color of the cyst content becomes clear. Then, 96% ethanol will be injected into the cyst. The volume of injected ethanol will be 60% of the first aspirated volume (maximum 100 ml). After 10 minutes all ethanol will be aspirated.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In eligible patients allocated to control group, no interventions will be done before ART cycle. |
| Ethanol sclerotherapy | Experimental | In eligible patients allocated to study group, endometrioma/s will be aspirated and treated with ethanol for 10 minutes 1-2 cycles before ART. Receives: Procedure: Ethanol Sclerotherapy for Endometrioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs
Measured: 18 months
Secondary outcomes (1)
pain scores
Visual Analog Pain Scale scores related to dysmenorrhea, dyspareunia, and/or pelvic pain will be measured before and after procedure. 0 is the lowest, 10 is the highest score. Higher the score means higher the pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 May 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Yavuz Emre Şükür, Ankara University
- Investigators
- Batuhan Aslan, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962775
- Sponsor's protocol ID
- AUTF
- Acronym
- START
- Status last verified
- Oct 2024
- First submitted
- 19 Jul 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 3283269Alborzi S, Ravanbakhsh R, Parsanezhad ME, Alborzi M, Alborzi S, Dehbashi S. A comparison of follicular response of ovaries to ovulation induction after laparoscopic ovarian cystectomy or fenestration and coagulation versus normal ovaries in patients with endometrioma. Fertil Steril. 2007 Aug;88(2):507-9. doi: 10.1016/j.fertnstert.2006.11.134. Epub 2007 Apr 11.
PubMed 17433319Benaglia L, Busnelli A, Biancardi R, Vegetti W, Reschini M, Vercellini P, Somigliana E. Oocyte retrieval difficulties in women with ovarian endometriomas. Reprod Biomed Online. 2018 Jul;37(1):77-84. doi: 10.1016/j.rbmo.2018.03.020. Epub 2018 Apr 13.
PubMed 29759886Benaglia 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 19502358Cohen 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 28579409Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.
PubMed 24435778Garcia-Velasco JA, Somigliana E. Management of endometriomas in women requiring IVF: to touch or not to touch. Hum Reprod. 2009 Mar;24(3):496-501. doi: 10.1093/humrep/den398. Epub 2008 Dec 4.
PubMed 19056774Hart RJ, Hickey M, Maouris P, Buckett W. Excisional surgery versus ablative surgery for ovarian endometriomata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004992. doi: 10.1002/14651858.CD004992.pub3.
PubMed 18425908Horton J, Sterrenburg M, Lane S, Maheshwari A, Li TC, Cheong Y. Reproductive, obstetric, and perinatal outcomes of women with adenomyosis and endometriosis: a systematic review and meta-analysis. Hum Reprod Update. 2019 Sep 11;25(5):592-632. doi: 10.1093/humupd/dmz012.
PubMed 31318420Meuleman C, Vandenabeele B, Fieuws S, Spiessens C, Timmerman D, D'Hooghe T. High prevalence of endometriosis in infertile women with normal ovulation and normospermic partners. Fertil Steril. 2009 Jul;92(1):68-74. doi: 10.1016/j.fertnstert.2008.04.056. Epub 2008 Aug 5.
PubMed 18684448Miquel L, Preaubert L, Gnisci A, Netter A, Courbiere B, Agostini A, Pivano A. Transvaginal ethanol sclerotherapy for an endometrioma in 10 steps. Fertil Steril. 2021 Jan;115(1):259-260. doi: 10.1016/j.fertnstert.2020.08.1422. Epub 2020 Oct 8.
PubMed 33039127Miquel L, Preaubert L, Gnisci A, Resseguier N, Pivano A, Perrin J, Courbiere B. Endometrioma ethanol sclerotherapy could increase IVF live birth rate in women with moderate-severe endometriosis. PLoS One. 2020 Sep 28;15(9):e0239846. doi: 10.1371/journal.pone.0239846. eCollection 2020.
PubMed 32986747Roustan A, Perrin J, Debals-Gonthier M, Paulmyer-Lacroix O, Agostini A, Courbiere B. Surgical diminished ovarian reserve after endometrioma cystectomy versus idiopathic DOR: comparison of in vitro fertilization outcome. Hum Reprod. 2015 Apr;30(4):840-7. doi: 10.1093/humrep/dev029. Epub 2015 Mar 3.
PubMed 25740883Rubod C, Jean Dit Gautier E, Yazbeck C. [Surgical management of endometrioma: Different alternatives in term of pain, fertility and recurrence. CNGOF-HAS Endometriosis Guidelines]. Gynecol Obstet Fertil Senol. 2018 Mar;46(3):278-289. doi: 10.1016/j.gofs.2018.02.013. Epub 2018 Mar 3. French.
PubMed 29510964Somigliana E, Benaglia L, Paffoni A, Busnelli A, Vigano P, Vercellini P. Risks of conservative management in women with ovarian endometriomas undergoing IVF. Hum Reprod Update. 2015 Jul-Aug;21(4):486-99. doi: 10.1093/humupd/dmv012. Epub 2015 Mar 6.
PubMed 25750209
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ethanol Sclerotherapy Before ART (Assisted Reproductive Technology) Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05962775
- Acronym / sponsor ID
- START / AUTF
- Conditions
- Endometrioma, Infertility, Sclerotherapy, ART, IVF
- Keywords
- endometrioma, ethanol sclerotherapy, assisted reproductive technology, in vitro fertilization, cumulative live birth rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are:
- Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma?
- Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates?
Infertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.
Detailed description
The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta-analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes.
Infertile patients aged 18-40 years with at least one endometrioma 4-10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti-mullerian hormone value below 0.3 ng/ml will not be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In eligible patients allocated to control group, no interventions will be done before ART cycle. |
| Ethanol sclerotherapy | Experimental | Procedure: Ethanol Sclerotherapy for EndometriomaIn eligible patients allocated to study group, endometrioma/s will be aspirated and treated with ethanol for 10 minutes 1-2 cycles before ART. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- AMH>0.3 ng/ml
- unilateral/bilateral endometrioma
- Endometrioma diameter 40-100 mm
Key exclusion criteria (7 listed)
- 3 or more IVF/embryo transfer failure
- Menstrual cycle abnormalities
- Male Factor infertility
- Presence of uterine fibroids
- Presence of hydrosalpinx
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol Sclerotherapy for Endometrioma2 gr IV cefazolin sodium will be administered 30 minutes before the procedure. The endometrioma cyst content will be aspirated by a single lumen needle, and the total aspirated volume calculation will be done. The endometrioma will then be washed with saline until the color of the cyst content becomes clear. Then, 96% ethanol will be injected into the cyst. The volume of injected ethanol will be 60% of the first aspirated volume (maximum 100 ml). After 10 minutes all ethanol will be aspirated. | Procedure or surgery | Ethanol sclerotherapy |
Primary outcome
Cumulative live birth rate
Time frame: 18 months
live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs
1 secondary outcome
pain scores
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 3283269Akamatsu 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.
- Background: PubMed 17433319Alborzi S, Ravanbakhsh R, Parsanezhad ME, Alborzi M, Alborzi S, Dehbashi S. A comparison of follicular response of ovaries to ovulation induction after laparoscopic ovarian cystectomy or fenestration and coagulation versus normal ovaries in patients with endometrioma. Fertil Steril. 2007 Aug;88(2):507-9. doi: 10.1016/j.fertnstert.2006.11.134. Epub 2007 Apr 11.
- Background: PubMed 29759886Benaglia L, Busnelli A, Biancardi R, Vegetti W, Reschini M, Vercellini P, Somigliana E. Oocyte retrieval difficulties in women with ovarian endometriomas. Reprod Biomed Online. 2018 Jul;37(1):77-84. doi: 10.1016/j.rbmo.2018.03.020. Epub 2018 Apr 13.
- Background: PubMed 19502358Benaglia 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.
- Background: PubMed 28579409Cohen 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.
- Background: PubMed 24435778Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.
- Background: PubMed 19056774Garcia-Velasco JA, Somigliana E. Management of endometriomas in women requiring IVF: to touch or not to touch. Hum Reprod. 2009 Mar;24(3):496-501. doi: 10.1093/humrep/den398. Epub 2008 Dec 4.
- Background: PubMed 18425908Hart RJ, Hickey M, Maouris P, Buckett W. Excisional surgery versus ablative surgery for ovarian endometriomata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004992. doi: 10.1002/14651858.CD004992.pub3.
- Background: PubMed 31318420Horton J, Sterrenburg M, Lane S, Maheshwari A, Li TC, Cheong Y. Reproductive, obstetric, and perinatal outcomes of women with adenomyosis and endometriosis: a systematic review and meta-analysis. Hum Reprod Update. 2019 Sep 11;25(5):592-632. doi: 10.1093/humupd/dmz012.
- Background: PubMed 18684448Meuleman C, Vandenabeele B, Fieuws S, Spiessens C, Timmerman D, D'Hooghe T. High prevalence of endometriosis in infertile women with normal ovulation and normospermic partners. Fertil Steril. 2009 Jul;92(1):68-74. doi: 10.1016/j.fertnstert.2008.04.056. Epub 2008 Aug 5.
- Background: PubMed 33039127Miquel L, Preaubert L, Gnisci A, Netter A, Courbiere B, Agostini A, Pivano A. Transvaginal ethanol sclerotherapy for an endometrioma in 10 steps. Fertil Steril. 2021 Jan;115(1):259-260. doi: 10.1016/j.fertnstert.2020.08.1422. Epub 2020 Oct 8.
- Background: PubMed 32986747Miquel L, Preaubert L, Gnisci A, Resseguier N, Pivano A, Perrin J, Courbiere B. Endometrioma ethanol sclerotherapy could increase IVF live birth rate in women with moderate-severe endometriosis. PLoS One. 2020 Sep 28;15(9):e0239846. doi: 10.1371/journal.pone.0239846. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Batuhan Aslan principal investigator
Ankara University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol Sclerotherapy for Endometrioma in people with Endometrioma and Infertility, run by Ankara University at 3 sites in Turkey (Türkiye).
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 7 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: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yavuz Emre Sukur (+905332409381, yesukur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: 18 months). 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 NCT05962775, which also lists 18 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 16 Oct 2024.