Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known diminished ovarian reserve (AMH < 1.0)

Known allergies to ethanol solutions

Pregnancy

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Laparoscopic sclerotherapy

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Laparoscopic Sclerotherapy1 intervention

Trial outcomes

Primary outcomes

1

AMH

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

Time frame
6 weeks
2

Antral Follicle Count

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

Time frame
6 weeks

Secondary outcomes

1

Endometrioma resolution

determine if endometrioma has resolved

Time frame
6 weeks
2

Endometrioma recurrence

Recurrence of ovarian endometrioma

Time frame
6 weeks
3

Post operative complications

Evaluate for any post op complications including, ER presentations and hospital admissions

Time frame
6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: