Suture of the Ovary After Enucleation of Ovarian Endometrioma

NCT03788720 | Not Yet Recruiting

• 1 other identifier: SOAVE-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrioma

Keywords

Endometrioma; Laparoscopy; Suture; Ovary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Suture

EXPERIMENTAL

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

Procedure: Suture of the ovarian cortex

No suture

SHAM COMPARATOR

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

Procedure: No suture of the ovarian cortex

Interventions

Suture of the ovarian cortex PROCEDURE

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).

Suture

No suture of the ovarian cortex PROCEDURE

Laparoscopic enucleation of endometriomas without suture of the ovarian cortex

No suture

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

"Filippo Del Ponte" Hospital

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Fabio Ghezzi, M.D.

  Università degli Studi dell'Insubria

  STUDY DIRECTOR

• Jvan Casarin, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Simone Garzon

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

+393296279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons who perform the surgery will be not masked for the treatment allocation. Evaluators (sonographers, data analyzers) will be blind for the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: December 28, 2018
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

IT (1)