Clinical trial NCT04355312: Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
Official title: Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cysts
Endometriosis
Fertility
Keywords: Laparoscopic Ovarian Cystectomy
Indocyanine Green to study ovarian vascularization
Fertility
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre Imagerie Cellulaire Santé, Faculté Médecine et Pharmacie, CLERMONT FERRAND
First posted: 2020-04-21
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* An adult woman of childbearing potential who has a desire for short-term pregnancy, under the age of 42, to undergo laparoscopic accessible surgical treatment (\<10 cm) for a benign organic ovarian cyst (serous, mucinous, dermoid or endometriotic) whose diagnosis was made on imaging (ultrasound or MRI).
* Patient able to provide informed consent to her participation in the study.
* Patient covered by the " Sécurité Social " insurance system.

Exclusion Criteria:

* Adult patient under protection, tutorship or curatorship.
* Refusal of the patient or poor understanding of the French language.
* Known allergy to iodine.
* Current pregnancy or breastfeeding

Primary outcomes:
measure: Fluorescence uptake or not at the area of cystectomy (binary criterion)
timeFrame: Inoperative
Secondary outcomes:
measure: METAMORPH Score
timeFrame: In immediate postoperative
measure: Rate of Side Effects
timeFrame: In per and immediate postoperative
measure: Added time
timeFrame: Immediate post operativ
measure: AMH dosage
timeFrame: Preoperatively
measure: AMH dosage
timeFrame: Month 6
measure: AMH dosage
timeFrame: Month 12
measure: Evaluation of the ovarian reserve by ultrasound by CFA
timeFrame: Preoperatively
measure: Evaluation of the ovarian reserve by ultrasound by CFA
timeFrame: Month 6
measure: Evaluation of the ovarian reserve by ultrasound by CFA
timeFrame: Month 12
measure: Number of Participants with Pregnancy
timeFrame: Month 6
measure: Number of Participants with Pregnancy
timeFrame: Month 12
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Anne-Sophie GREMEAU
role: PRINCIPAL_INVESTIGATOR
References: