Suture of the Ovary After Enucleation of Ovarian Endometrioma

Not Applicable

Not yet recruiting

• Conditions: Endometrioma
• Interventions: Procedure: No suture of the ovarian cortex; Procedure: Suture of the ovarian cortex

• Registration Number: NCT03788720
• Lead Sponsor: Università degli Studi dell'Insubria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29
• Study Start: 2023-05
• Primary Completion: 2025-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No suture	No suture of the ovarian cortex	Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
Suture	Suture of the ovarian cortex	Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.

Primary Outcome Measures

Name	Time	Method
Antral Follicle Count (AFC)	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	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.

Secondary Outcome Measures

Name	Time	Method
Ovarian volume	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	Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)
Pulsatility index, evaluated by Doppler flowmetry, 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	Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.
Resistive index, evaluated by Doppler flowmetry, 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	Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.

Trial Locations

Locations (1)

"Filippo Del Ponte" Hospital; 🇮🇹 Varese, Italy