Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

Tanta University

Status and phase: Completed; Early Phase 1

Conditions: Endometriosis

Treatments: Drug: Ethanol Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05470972

35560/6/22

Details and patient eligibility

About

Design: Prospective interventional study. 69 women with OE were evaluated clinically and by transvaginal ultrasonography (TUV). AEST procedure was performed and the collected aspirate and pre-procedural blood samples were collected for estimation of cytokines' levels. At 6-m post-procedure, clinical evaluation and TUV were repeated and serum cytokines' levels were re-estimated.

Enrollment: 69 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with OE of a mean diameter of >3 cm

Exclusion criteria

• Women with recurrent OE
• a cyst that was suspicious of being malignant
• diabetes mellitus
• polycystic ovary syndrome
• body mass index (BMI) of >30 kg/m2
• previous surgical interference that resulted in pelvic adhesions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Ovarian Endometrioma

Experimental group

Description:

Ovarian endometrioma (OE) is in women of reproductive age

Treatment:

Drug: Ethanol Injection