UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ayman.dawood@med.tanta.edu.eg

Sponsor
Institute	Tanta university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030861