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Not Yet RecruitingNCT03788720

Suture of the Ovary After Enucleation of Ovarian Endometrioma

Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Università degli Studi dell'Insubria · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESuture of the ovarian cortexSuture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).
PROCEDURENo suture of the ovarian cortexLaparoscopic enucleation of endometriomas without suture of the ovarian cortex

Timeline

Start date
2023-05-01
Primary completion
2025-05-01
Completion
2027-05-01
First posted
2018-12-28
Last updated
2021-04-29

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03788720. Inclusion in this directory is not an endorsement.