Suture of the Ovary After Enucleation of Ovarian Endometrioma

Endometrioma Clinical Trial

— SOAVE-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03788720
• Other study ID #: SOAVE-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: May 2027

Study information

• Verified date: April 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: +393296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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);

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

Procedure:
• Suture of the ovarian cortex
Suture 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).
• No suture of the ovarian cortex
Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

Locations

Country	Name	City	State
Italy	"Filippo Del Ponte" Hospital	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral Follicle Count (AFC)	AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.	Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Secondary	Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery	Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.	Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Secondary	Resistive index, evaluated by Doppler flowmetry, of the ovarian artery	Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.	Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
Secondary	Ovarian volume	Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)	Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery