Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
Condition: Ovarian Cysts; Endometriosis; Fertility
MeSH terms: Ovarian Cysts; Endometriosis; Neovascularization, Pathologic
Study type: Interventional

Summary: 
      To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment
      of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients
      with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery
      could allow early evaluation of the absence of alteration of the underlying ovary by the
      cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be
      compared to the ovarian reserve of the patient, previously verified intraoperatively and
      postoperatively at M6 and M12, these scores being determined according to the vascularization
      visualized in laparoscopy and established both by a double visual notation (Likert scale) and
      by a computer software (METAMORPH) objective notation. This procedure would, in patients with
      fertility disorders or wishing for pregnancy in the short run, reassure them about their
      reproductive potential immediately after the intervention. In the event of poor staining, if
      correlated by a decrease in ovarian reserve, the concerned patients could be referred to a
      MPA treatment facility much earlier in the postoperative period or, if no desire for
      immediate pregnancy, towards fertility preservation methods.
    

Detailed description: 
      The study will be open to any patient meeting the inclusion / exclusion criteria, scheduled
      for intraperitoneal cystectomy or cyst destruction using Plasmajet, corresponding to a benign
      organic cyst requiring surgical treatment according to current recommendations.

      It will proceed as follows:

        -  Recruitment of patients during the preoperative consultation. The information form will
           be given to the patient.

        -  The day before the intervention: Inclusion proposed to the patient after re-explanation
           of the objectives and the progress of the study, submission of the consent form for the
           patient to sign. Realization of an ultrasound with count of antral follicles, and
           description of the ovarian cyst (size, aspect, IOTA criteria). Performing a blood test
           with AMH measurement to assess the preoperative ovarian reserve.

        -  The day of the intervention: Intraoperative, injection at the end of the procedure of a
           bolus of indocyanine green intravenously. Studied through an infrared camera system -
           the SPIES system (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany) - fluorescence within
           the ovary will bring out the vascularization of the area of cystectomy or destruction of
           the cyst. Evaluation of the degree of fluorescence (between 0 and 4, on the model of a
           Likert scale) carried out at the area of cystectomy or destruction of the cyst. Then,
           the second evaluation technique using the METAMORPH software will assign a raw and
           objective score according to the fluorescence visualized. The 2 evaluation results will
           be compared with each other.

        -  Postoperatively: there will be no special clinical or biological monitoring. If
           undesirable effects related to Indocyanine Green occur, they will be noted.

        -  After discharge, as part of her standard follow-up for short-term desire for pregnancy:
           she will have a postoperative consultation planned 1 month after the intervention,
           followed by examination at 6 months and 12 months with an ultrasound for evaluation CFA
           and blood work with AMH.

      Any natural pregnancy will be noted.
    

Intervention name(s): Use of Indocyanine Green in laparoscopic ovarian cystectomy
Intervention type(s): Diagnostic Test
Intervention description(s): During intraperitoneal cystectomy or Plasmajet destruction of the cyst, as a benign organic cyst requiring surgical treatment, peroperatively, at the end of the cystectomy procedure, injection by the anesthetist on a peripheral venous route of a bolus of Indocyanine green diluted 0.2mg / kg. Installation of the SPIES camera system (KARL STORZ GmbH & Co.KG, Tuttlingen, Germany).
Evaluation of the degree of fluorescence at the location of cystectomy or destruction of the cyst.
A fluorescence score between 0 and 4 (on the model of a Likert scale) will be used for the evaluation of fluorescence.
A second reading of the Likert scale results will be carried out by a second inspector so that the score is as objective as possible. Then, second evaluation technique realized by the METAMORPH software, which will assign a raw and objective score according to the fluorescence visualized.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Laparoscopic Ovarian Cystectomy; Indocyanine Green to study ovarian vascularization; Fertility