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Not yet recruiting NCT03788720

Suture of the Ovary After Enucleation of Ovarian Endometrioma

No phase Interventional Endometrioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suture of the ovarian cortex, No suture of the ovarian cortex.
Who it may be relevant to
Registry conditions: Endometrioma. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility 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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • "Filippo Del Ponte" Hospital — Varese

Identifiers

NCT: NCT03788720 · SOAVE-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗