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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016884
Receipt No. R000019600
Scientific Title A comparison of Hysterosalpingo-foam sonography (HyFoSy) and Hysterosalpingo-contrast sonography with saline medium (HyCoSy) in the assessment of tubal patency
Date of disclosure of the study information 2015/03/23
Last modified on 2015/03/23

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Basic information
Public title A comparison of Hysterosalpingo-foam sonography (HyFoSy) and Hysterosalpingo-contrast sonography with saline medium (HyCoSy) in the assessment of tubal patency
Acronym A comparison of Hysterosalpingo-foam sonography (HyFoSy) and Hysterosalpingo-contrast sonography with saline medium (HyCoSy) in the assessment of tubal patency
Scientific Title A comparison of Hysterosalpingo-foam sonography (HyFoSy) and Hysterosalpingo-contrast sonography with saline medium (HyCoSy) in the assessment of tubal patency
Scientific Title:Acronym A comparison of Hysterosalpingo-foam sonography (HyFoSy) and Hysterosalpingo-contrast sonography with saline medium (HyCoSy) in the assessment of tubal patency
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 We performed a randomised controlled selective cross- over trial to compare the diagnostic yield and efficacy of ExEm foam (HyFoSy) with saline medium (HyCoSy) as a contrast agent for hysterosalping- contrast sonography in subfertile patients.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The following outcome measures were used to assess diagnostic yield:
- Proportion of patent tubes detected with the initial tubal patency test.
- Proportion of possibly occluded or unexaminable tubes that were re- classified as patent on cross- over testing.

Efficacy was defined as the proportion of patients who required cross- over testing (i.e had at least one possibly occluded or unexaminable tube on the initial tubal patency test).
Key secondary outcomes

Base
Study type

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 A routine non- contrast vaginal ultrasound assessment of the pelvic organs was performed before tubal evaluation. The procedure for HyCoSy using saline medium was as follows: The cervix was visualised with a Cussco speculum and cleaned with an antiseptic. A No. 5 pediatric Foley catheter was introduced into the cervical os, using a tenaculum if necessary. The balloon was positioned in the lower uterine cavity and inflated with 2 ml of saline to prevent backflow of contrast medium through the cervix. The speculum was removed and the vaginal transducer was reintroduced in the longitudinal plane to confirm correct placement of the catheter. Sterile normal saline (0.9% NaCl) in a 20- ml syringe was introduced into the endometrial cavity while observing the uterine cornua at the transverse plane using B- mode and colour Doppler. After tubal evaluation is completed, the balloon is deflated and up to 5 ml of normal saline instilled to look for intracavitary lesions.
Interventions/Control_2 The procedure for HyFoSy was as follows The cervix was visualised and cleansed in the same manner as with HyCoSy. The prepackaged balloon less cervical catheter was introduced into the cervical os, using a tenaculum if necessary. The speculum was removed and the vaginal transducer was reintroduced in the longitudinal plane. Up to 5 ml of sterile water was instilled to confirm correct placement of the catheter and look for intracavitary lesions then re aspirated before proceeding to tubal evaluation. 20 ml of foam contrast was reconstituted from ExEm gel and water according to the manufacturers instructions and introduced into the endometrial cavity while observing the uterine cornua at the transverse plane using B mode.
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
21 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria All patients referred for tubal patency assessment at the Singapore General Hospitals Centre for Assisted Reproduction were invited to participate. Inclusion criteria were subfertile women who required office tubal patency evaluation after assessment by a consultant gynaecologist.
Key exclusion criteria Exclusion criteria were age below the legal limit for consent (21 years old), inability to give informed consent, active pelvic infection, active uterine bleeding (including menstruation) and refusal to undergo cross- over testing
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Lim Liqing Serene
Organization Singapore General Hospital
Division name Obstetrics and Gynecology
Zip code
Address 1 Hospital Drive Singapore 169608
TEL 8121630
Email pluiepluie@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Lim Liqing Serene
Organization Singapore General Hospital
Division name Obstetrics and Gynecology
Zip code
Address 1 Hospital Drive
TEL 81211630
Homepage URL
Email pluiepluie@gmail.com

Sponsor
Institute Neuvital Pte Ltd
Institute
Department

Funding Source
Organization Neuvital Pte Ltd
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
Email

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
2015 Year 03 Month 23 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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 23 Day
Last modified on
2015 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019600

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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