Health TrialsbyHealthPanel

Endometrioma Sclerotherapy and Ovarian Preservation

ConditionEndometrioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorChelsea and Westminster NHS Foundation Trust

About this trial

A randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma.

Secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female (XX genotype, assigned female at birth)

Age 18-40

Finding of suspected uni- or bi-lateral ovarian endometrioma(ta) of ≥ 2cm on TVUSS and/or pelvic MRI scan (TVUSS, a uni- or multi-locular ovarian cystic lesion with low level echoes and diffuse homogeneous ground glass appearance; MRI any of, ovarian lesion hyperintense T1 without loss of signal on T1 fat-suppressed images, hypointense T2 exhibiting shading sign and/or T2 dark spot sign, variable restricted diffusion on DWI)

Appropriate to be listed for laparoscopic excision of endometrioma (Endometrioma ≥2cm, pain symptoms attributable to endometriosis where medical management is unsuccessful or unacceptable to the patient, to facilitate ART)

Disqualifiers

Postmenopausal status

Suspicion of malignancy

Unable to undergo TVUSS

Declines to take part in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sclerotherapy

    Procedure/Surgery

    Laparoscopic ethanol sclerotherapy of endometrioma

  • Routine Care

    Procedure/Surgery

    Routine surgical management of endometrioma

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Surgical Management of EndometriomaOther 1 intervention
Group B: Laparoscopic SclerotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ovarian Reserve

To determine the statistical difference in ovarian reserve pre- and post- treatment (as measured by serum AMH at 3, 6, 12 and 24 months and antral follicle count at 6, 12 and 24 months) in participants randomised to receive laparoscopic ethanol sclerotherapy or laparoscopic excision of endometrioma

Time frame
24 months

Secondary outcomes

1

Endometrioma recurrence

To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters recurrence of ovarian endometrioma (as measured by TVUSS at 6, 12 and 24 months) as compared to laparoscopic excision of endometrioma

Time frame
24 monhts
2

Symptomatology

To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma affects symptomatology (as recorded by EHP-30) as compared to laparoscopic excision of endometrioma at 3, 6, 12 and 24 months

Time frame
24 monhts
3

Inflammation

To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters the inflammatory environment (as measured in blood at 3, 6, 12 and 24 months, and endometrial biopsy at 6 months) as compared to laparoscopic excision of endometrioma

Time frame
24 monhts

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chelsea and Westminster NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov
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