UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022490 |
|---|---|
| Receipt number | R000025916 |
| Scientific Title | Non-randomized, single arm study of the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after hysteroscopic surgery. |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2023/06/08 09:47:01 |
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Basic information
Public title
Non-randomized, single arm study of the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after hysteroscopic surgery.
Acronym
A study of the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after hysteroscopic surgery.
Scientific Title
Non-randomized, single arm study of the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after hysteroscopic surgery.
Scientific Title:Acronym
A study of the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after hysteroscopic surgery.
Region
| Japan |
Condition
Condition
Intrauterine Adhesion (Asherman syndrome), Uterine septum.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Investigate the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intrauterine adhesion rate after one year following hysteroscopic surgery for preventing intrauterine adhesion.
Key secondary outcomes
Intrauterine adhesion rate after two months following hysteroscopic surgery for preventing intrauterine adhesion.
Pregnancy rate after one year following hysterscopic surgery for preventing intrauterine adhesion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Insertion of intrauterine silicone plate.
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
| Not applicable |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Intrauterine adhesion(Asherman syndrome) ,Uterine septum
2. Infertility or Recurrent pregnancy loss
3.Patients who plan to undergo hysteroscopic adhesiolysis or hysteroscopic uterine septum resection
Key exclusion criteria
1.Women who don't desire to conceive
2.Patients with severe immunocompromised state
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Aoki |
Organization
University of the Ryukyus
Division name
Graduate School of Medical Science University of the Ryukyus
Zip code
9030215
Address
207 Uehara, Nishihara, Okinawa
TEL
098-895-1177
yoichi@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Mekaru |
Organization
University of the Ryukyus Hospital
Division name
Obstetrics and gynecology
Zip code
9030215
Address
207 Uehara, Nishihara, Okinawa
TEL
098-895-1177
Homepage URL
f041252@eve.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of University of the Ryukyus for Clinical Research
Address
207 Uehara, Nishihara, Okinawa
Tel
098-895-8016
knknkyu@to.jim.u-ryukyu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025916
