UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026900 |
|---|---|
| Receipt number | R000030861 |
| Scientific Title | Outcome of laparoscopic adhesiolysis for infertile patients with pelvic adhesions following cesarean delivery: A randomized clinical trial |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2020/10/20 20:16:40 |
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Basic information
Public title
Outcome of laparoscopic adhesiolysis for infertile patients with pelvic adhesions following cesarean delivery: A randomized clinical trial
Acronym
Outcome of laparoscopic adhesiolysis for infertile patients with pelvic adhesions following cesarean delivery: A randomized clinical trial
Scientific Title
Outcome of laparoscopic adhesiolysis for infertile patients with pelvic adhesions following cesarean delivery: A randomized clinical trial
Scientific Title:Acronym
Outcome of laparoscopic adhesiolysis for infertile patients with pelvic adhesions following cesarean delivery: A randomized clinical trial
Region
| Africa |
Condition
Condition
finished
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the prevalence of adhesions in the secondary infertility patients and the outcome of adhesiolysis in relation to pregnancy rate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feasibility of adhesiolysis
Key secondary outcomes
occurrence of pregnancy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
adhesiolysis
Interventions/Control_2
no adhesiolysis
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Unexplained infertility occurring after previous cesarean delivery and patients other investigations were normal, patients accepting and fit for laparoscopy.
Key exclusion criteria
patients with other causes as uterine , ovarian, male factors or tubal block. patients unfit for laparoscopy or denied to participate
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
tanta university
Division name
Ayma shehata dawood
Zip code
31111
Address
Tanta university
TEL
+201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Ayman shehata dawood
Zip code
31111
Address
Tanta university
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta university
Institute
Department
Personal name
Funding Source
Organization
Tanta university
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
Tanta university
Address
Elgeish st., Tanta, Egypt
Tel
+201020972067
ayman.dawood@med.tanta.edu.eg
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
| 2017 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030861
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