Suture of the Ovary After Enucleation of Ovarian Endometrioma (SOAVE-1)

Università degli Studi dell'Insubria

Status: Not yet enrolling

Conditions: Endometrioma

Treatments: Procedure: Suture of the ovarian cortex; Procedure: No suture of the ovarian cortex

Study type: Interventional

Funder types: Other

Identifiers

NCT03788720

SOAVE-1

Details and patient eligibility

About

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.

According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).

To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.

In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
• Normal AFC at the enrollment (baseline).

Exclusion criteria

• Any other disease;
• Bilateral endometriomas;
• Deep infiltrating endometriosis;
• No previous pelvic surgery (even not gynecological);
• Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Suture

Experimental group

Description:

Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.

Treatment:

Procedure: Suture of the ovarian cortex

No suture

Sham Comparator group

Description:

Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.

Treatment:

Procedure: No suture of the ovarian cortex