Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas

NCT07481617 | Not Yet Recruiting

• 1 other identifier: STU00225154
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the effect of laparoscopic sclerotherapy on ovarian reserve and its overall efficacy in the treatment of endometriomas. Ovarian reserve will be assessed using preoperative and postoperative anti-Müllerian hormone (AMH) levels and antral follicle count (AFC). Traditionally, ovarian endometriomas are managed by complete cystectomy; however, multiple studies including a large systematic review and meta-analysis-have demonstrated that cystectomy significantly reduces ovarian reserve, with an average decline in AMH of 1.77 ng/mL within one to six weeks postoperatively without recovery to baseline after many months. Sclerotherapy has historically been a potential alternative, typically performed by interventional radiology via transvaginal, transabdominal, or transgluteal drainage. This percutaneous approach, however, precludes direct visualization of the cyst and surgical management of concurrent conditions including endometriosis peritoneal disease, excision, adhesions, or tubal disease. Several studies have explored the feasibility and effectiveness of laparoscopic sclerotherapy, reporting encouraging results regarding its safety, increased AFC compared with cystectomy, and comparable pregnancy rates. Nonetheless, none of these studies have been conducted in the United States, and few have utilized a laparoscopic approach. Further research is therefore warranted to establish the accessibility and reproducibility of this technique. The investigators aim to conduct the first U.S.-based study evaluating the impact of laparoscopic sclerotherapy on ovarian reserve. The primary outcome will be the change in AMH and AFC at six weeks postoperatively. Consistent with prior evidence, the investigators hypothesize that laparoscopic sclerotherapy will result in a smaller decline in ovarian reserve compared with traditional cystectomy.

Conditions

Endometriosis; Endometrioma; Sclerotherapy; Laparoscopy

Keywords

laparoscopic sclerotherapy

Outcome Measures

Primary Outcomes (2)

• AMH

  Change in AMH from pre op appintment to 6 week post op appointment.

  6 weeks

• Antral Follicle Count

  An Ultrasound will be performed at 6 weeks post op to assess antral follicle count

  6 weeks

Secondary Outcomes (3)

• Endometrioma resolution

  6 weeks

• Endometrioma recurrence

  6 weeks

• Post operative complications

  6 weeks

Study Arms (1)

Laparoscopic Sclerotherapy

Patients who choose to undergo laparoscopic sclerotherapy for management of their ovarian endometrioma.

Procedure: Laparoscopic sclerotherapy

Interventions

Laparoscopic sclerotherapy PROCEDURE

Standard of care for an endometrioma is a laparoscopic cystectomy. This procedure still uses laparoscopy however instead of a cystectomy, the ovarian cyst is drained and ethanol is instilled for sclerotherapy and then removed from the cyst. The benefit is hopefully a lesser impact on ovarian reserve as opposed to ovarian cystectomy.

Laparoscopic Sclerotherapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with at least one endometrioma \> 4 cm, interested in ovarian conservation and surgical management of the endometrioma.

You may qualify if:

• English speaking
• Age of 18 or greater
• At least one ovarian endometrioma \> 4 cm in size
• Desires to proceed with surgical management of the endometrioma

You may not qualify if:

• Known diminished ovarian reserve (AMH \< 1.0)
• Known allergies to ethanol solutions
• Pregnancy

Sponsors & Collaborators

• Northwestern University: lead

Related Publications (10)

• 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.

  PMID: 41186685 BACKGROUND

• Crestani A, Merlot B, Goualard PH, Huet C, Husson Z, Dennis T, Chanavaz-Lacheray I, Roman H. Laparoscopic sclerotherapy for ovarian endometriomas during surgery for deep endometriosis: Outcomes of a 134-patient cohort. Int J Gynaecol Obstet. 2025 Oct;171(1):431-437. doi: 10.1002/ijgo.70201. Epub 2025 May 7.

  PMID: 40332134 BACKGROUND

• 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.

  PMID: 36228863 BACKGROUND

• Veth VB, Keukens A, Reijs A, Bongers MY, Mijatovic V, Coppus SFPJ, Maas JWM. Recurrence after surgery for endometrioma: a systematic review and meta-analyses. Fertil Steril. 2024 Dec;122(6):1079-1093. doi: 10.1016/j.fertnstert.2024.07.033. Epub 2024 Aug 5.

  PMID: 39098538 BACKGROUND

• Lavadia CMM, Jeong HG, Ryu KJ, Park H. Ovarian reserve and IVF outcomes after ethanol ovarian sclerotherapy in women with endometrioma: a systematic review and meta-analysis. Reprod Biomed Online. 2025 Jul;51(1):104840. doi: 10.1016/j.rbmo.2025.104840. Epub 2025 Feb 16.

  PMID: 40440796 BACKGROUND

• Martinez-Garcia JM, Candas B, Suarez-Salvador E, Gomez M, Merino E, Castellarnau M, Carreras M, Carrarach M, Subirats N, Gonzalez S, Fernandez-Montoli E, Ponce J, Garcia-Tejedor A. Comparing the effects of alcohol sclerotherapy with those of surgery on anti-Mullerian hormone and ovarian reserve after endometrioma treatment. A prospective multicenter pilot cohort study. Eur J Obstet Gynecol Reprod Biol. 2021 Apr;259:60-66. doi: 10.1016/j.ejogrb.2021.01.027. Epub 2021 Jan 22.

  PMID: 33592391 BACKGROUND

• Fisch JD, Sher G. Sclerotherapy with 5% tetracycline is a simple alternative to potentially complex surgical treatment of ovarian endometriomas before in vitro fertilization. Fertil Steril. 2004 Aug;82(2):437-41. doi: 10.1016/j.fertnstert.2004.01.031.

  PMID: 15302295 BACKGROUND

• Younis JS, Shapso N, Ben-Sira Y, Nelson SM, Izhaki I. Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Mullerian hormone. Am J Obstet Gynecol. 2022 Jan;226(1):33-51.e7. doi: 10.1016/j.ajog.2021.06.102. Epub 2021 Jul 13.

  PMID: 34265271 BACKGROUND

• Alborzi S, Zahiri Sorouri Z, Askari E, Poordast T, Chamanara K. The success of various endometrioma treatments in infertility: A systematic review and meta-analysis of prospective studies. Reprod Med Biol. 2019 Jun 19;18(4):312-322. doi: 10.1002/rmb2.12286. eCollection 2019 Oct.

  PMID: 31607791 BACKGROUND

• 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.

  PMID: 28579409 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Magdy Milad, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Pope, MD

CONTACT

3126946773; hannah.pope@nm.org

Juan Avitia, MPH

CONTACT

juan.avitia1@nm.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Albert B Gerbie Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 19, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share