Ovarian CystsKYSINDONCT04355312
Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
A study testing Use of Indocyanine Green in laparoscopic ovarian cystectomy in people with Ovarian Cysts and Endometriosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Ovarian Cysts, Endometriosis, Fertility
- What is being tested?
- Use of Indocyanine Green in laparoscopic ovarian cystectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ovarian Cysts, Endometriosis, Fertility
- Being tested
- Use of Indocyanine Green in laparoscopic ovarian cystectomy
- Keywords
- Laparoscopic Ovarian Cystectomy, Indocyanine Green to study ovarian vascularization, Fertility
- Medical subject headings
- Ovarian Cysts, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Indocyanine Green in laparoscopic ovarian cystectomyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Kysindo | Experimental | 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. Receives: Diagnostic Test: Use of Indocyanine Green in laparoscopic ovarian cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence uptake or not at the area of cystectomy (binary criterion)
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.
Measured: Inoperative
Secondary outcomes (11)
METAMORPH Score
Automatic and objective allocation by the METAMORPH software of a raw score according to the fluorescence visualized.
Measured: In immediate postoperative
Rate of Side Effects
Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green.
Measured: In per and immediate postoperative
Added time
Estimation of the protocol-related time added to the total operating time.
Measured: Immediate post operativ
AMH dosage
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Preoperatively
AMH dosage
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Month 6
AMH dosage
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Month 12
Evaluation of the ovarian reserve by ultrasound by CFA
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Preoperatively
Evaluation of the ovarian reserve by ultrasound by CFA
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Month 6
Evaluation of the ovarian reserve by ultrasound by CFA
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Month 12
Number of Participants with Pregnancy
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Month 6
Number of Participants with Pregnancy
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start15 Jun 2020
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Imagerie Cellulaire Santé, Faculté Médecine et Pharmacie, CLERMONT FERRAND
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie GREMEAU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355312
- Sponsor's protocol ID
- AOI 2019 GREMEAU
- Other IDs
- 2019-001966-14, 2019
- Acronym
- KYSINDO
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gremeau 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.
PubMed 42335746
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
- ClinicalTrials.gov ID
- NCT04355312
- Acronym / sponsor ID
- KYSINDO / AOI 2019 GREMEAU
- Conditions
- Ovarian Cysts, Endometriosis, Fertility
- Keywords
- Laparoscopic Ovarian Cystectomy, Indocyanine Green to study ovarian vascularization, Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre Imagerie Cellulaire Santé, Faculté Médecine et Pharmacie, CLERMONT FERRAND
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kysindo | Experimental | Diagnostic Test: Use of Indocyanine Green in laparoscopic ovarian cystectomyGroup 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Indocyanine Green in laparoscopic ovarian cystectomyDuring 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. | Diagnostic test | Kysindo |
Primary outcome
Fluorescence uptake or not at the area of cystectomy (binary criterion)
Time frame: Inoperative
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.
11 secondary outcomes
METAMORPH Score
Time frame: In immediate postoperative
Rate of Side Effects
Time frame: In per and immediate postoperative
Added time
Time frame: Immediate post operativ
AMH dosage
Time frame: Preoperatively
AMH dosage
Time frame: Month 6
AMH dosage
Time frame: Month 12
Evaluation of the ovarian reserve by ultrasound by CFA
Time frame: Preoperatively
Evaluation of the ovarian reserve by ultrasound by CFA
Time frame: Month 6
Evaluation of the ovarian reserve by ultrasound by CFA
Time frame: Month 12
Number of Participants with Pregnancy
Time frame: Month 6
Number of Participants with Pregnancy
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 42335746Gremeau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie GREMEAU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Indocyanine Green in laparoscopic ovarian cystectomy in people with Ovarian Cysts and Endometriosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescence uptake or not at the area of cystectomy (binary criterion) (time frame: Inoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.