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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034585
Receipt No. R000039424
Official scientific title of the study Tubal dye test and lymphatic dissemination of endometriosis
Date of disclosure of the study information 2018/11/15
Last modified on 2018/10/21

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Basic information
Official scientific title of the study Tubal dye test and lymphatic dissemination of endometriosis
Title of the study (Brief title) Tubal dye test and endometriosis
Region
Europe

Condition
Condition Endometriosis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A peculiar effect of the dye was noted as it permeated the uterine wall and a clear passage of the dye was shown in the pelvic lymphatic vessels regardless whether the tubes were unobstructed. Laparoscopic dye test was performed using an intrauterine catheter to verify tubal permeability. Deep infiltrating endometriosis lesions were removed during laparoscopy and uterine biopsy was taken.
Basic objectives2 Others
Basic objectives -Others This study took the cue from an observation: During a laparoscopic procedure in an infertile woman with presurgical evidence of endometriosis, the dye test to verify tubal permeability showed a peculiar effect on the uterine wall. Some areas of the external layer of the myometrium showed a pale blue color and, notwithstanding both tubes were unobstructed, the drainage of the dye from the uterine cavity was noted along the infundibulopelvic ligament through lymphatic vessels.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the reason why the methilen blue dye drains through extrauterine structures
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 All women with endometriosis who undergo laparoscopy for infertility have a tubal permeability test injecting a diluted methylene blue solution into the uterine cavity.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria Infertility; endometriosis
Key exclusion criteria Age lower than 16 years; previous tubal removal;
Target sample size 100

Research contact person
Name of lead principal investigator Marco Scioscia
Organization Sacro Cuore Don Calabria Hospital
Division name Obstetrics and Gynecology
Address Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL +393498724206
Email marcoscioscia@gmail.com

Public contact
Name of contact person Marco Scioscia
Organization Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Division name Obstetrics and Gynecology
Address Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL +393498724206
Homepage URL
Email marcoscioscia@gmail.com

Sponsor
Institute Sacro Cuore Don Calabria Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Sacro Cuore Don Calabria Hospital

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 15 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 26 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2017 Year 11 Month 01 Day
Date of closure to data entry
2018 Year 01 Month 21 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 10 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results Between September 2016 and January 2018, 191 patients underwent laparoscopy for endometriosis (Table 1). In 104 cases (55%), a tubal permeability test (dye test) was carried out as the patients were infertile. It is not unusual to observe during a laparoscopic tubal dye test a color change, at least in some areas, of the adenomyotic uterus from pale to deep blue. In fact, a change of color of the uterus was noted in 27 cases (26%) that in some cases extended to extrauterine organs.
Other related information

Management information
Registered date
2018 Year 10 Month 21 Day
Last modified on
2018 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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