UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034585 |
|---|---|
| Receipt number | R000039424 |
| Scientific Title | Tubal dye test and lymphatic dissemination of endometriosis |
| Date of disclosure of the study information | 2018/11/15 |
| Last modified on | 2018/10/21 02:49:10 |
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Basic information
Public title
Tubal dye test and lymphatic dissemination of endometriosis
Acronym
Tubal dye test and endometriosis
Scientific Title
Tubal dye test and lymphatic dissemination of endometriosis
Scientific Title:Acronym
Tubal dye test and endometriosis
Region
| Europe |
Condition
Condition
Endometriosis
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Sacro Cuore Don Calabria Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL
+393498724206
marcoscioscia@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marco Scioscia |
Organization
Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy
Division name
Obstetrics and Gynecology
Zip code
Address
Via Sempreboni 5 - 37024 Negrar (VR), Italy
TEL
+393498724206
Homepage URL
marcoscioscia@gmail.com
Sponsor or person
Institute
Sacro Cuore Don Calabria Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039424
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
