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

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ClinicalTrials.gov Identifier: NCT03788720
Recruitment Status : Not yet recruiting
First Posted : December 28, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, 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.


Condition or disease Intervention/treatment Phase
Endometrioma Procedure: Suture of the ovarian cortex Procedure: No suture of the ovarian cortex Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Surgeons who perform the surgery will be not masked for the treatment allocation.

Evaluators (sonographers, data analyzers) will be blind for the treatment allocation.

Primary Purpose: Treatment
Official Title: Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Experimental: Suture
Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.
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).

Sham Comparator: No suture
Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
Procedure: No suture of the ovarian cortex
Laparoscopic enucleation of endometriomas without suture of the ovarian cortex




Primary Outcome Measures :
  1. Antral Follicle Count (AFC) [ Time Frame: 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 :
  1. Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery [ Time Frame: 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.

  2. Resistive index, evaluated by Doppler flowmetry, of the ovarian artery [ Time Frame: 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.

  3. Ovarian volume [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788720


Contacts
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Contact: Antonio Simone Laganà, M.D. +393296279579 antoniosimone.lagana@asst-settelaghi.it

Locations
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Italy
"Filippo Del Ponte" Hospital
Varese, Italy, 21100
Contact: Antonio Simone Laganà, M.D.    +393296279579    antoniosimone.lagana@asst-settelaghi.it   
Sub-Investigator: Davide Sturla, M.D.         
Sub-Investigator: Giulia Bordi, M.D.         
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria
Study Director: Fabio Ghezzi, M.D. Università degli Studi dell'Insubria
Principal Investigator: Jvan Casarin, M.D. Università degli Studi dell'Insubria
Principal Investigator: Simone Garzon Università degli Studi dell'Insubria

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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03788720    
Other Study ID Numbers: SOAVE-1
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Endometrioma
Laparoscopy
Suture
Ovary
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female