UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016884 |
|---|---|
| Receipt number | 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 21:21:07 |
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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
| Obstetrics 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
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
pluiepluie@gmail.com
Sponsor or person
Institute
Neuvital Pte Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019600
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