Clinical trial · Interventional
Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometriosis | — | UNRESOLVED | — |
| Fertility | — | UNRESOLVED | — |
| Ovarian Cysts | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Use of Indocyanine Green in laparoscopic ovarian cystectomy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Kysindo
- description
- Group of 45 patients with short-term desire for pregnancy who will undergo laparoscopic ovarian cystectomy with use of indocyanine green. Evaluation of the ovarian reserve preoperatively and longitudinal cohort follow-up after surgery at 6 months and 12 months. Analysis by a new imaging technique.
- interventionNames
- Diagnostic Test: Use of Indocyanine Green in laparoscopic ovarian cystectomy
Primary outcomes (1)
- measure
- Fluorescence uptake or not at the area of cystectomy (binary criterion)
- timeFrame
- Inoperative
- description
- A fluorescence score based on a Likert scale will be used. The presence of fluorescence will correspond to a success, defined by a value on the scale strictly greater than 0. The absence of fluorescence will be a failure, defined as equal to 0. The judgment criterion will therefore be binary (fluorescence uptake or no at the area of cystectomy), allowing the feasibility judgement.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 42 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTGremeau AS, Julien A, Bourdel N, Brugnon F, Comptour A, Jacobs A, Pereira B, Novais-Gameiro L, Canis M. Ovarian vascularisation assessment using indocyanine green after laparoscopic treatment of ovarian cysts - A feasibility study. Eur J Obstet Gynecol Reprod Biol. 2026 Aug;324:115249. doi: 10.1016/j.ejogrb.2026.115249. Epub 2026 Jun 20. PMID 42335746