UMIN-CTR Clinical Trial

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
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IRB Contact (For public release)
Organization
Address
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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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