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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Reproductive Medicine | |
Classification by specialty |
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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.
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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 |
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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. | ||
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Eligibility | ||||
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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 |
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Organization | Singapore General Hospital | ||||||
Division name | Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 1 Hospital Drive Singapore 169608 | ||||||
TEL | 8121630 | ||||||
pluiepluie@gmail.com |
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Organization | Singapore General Hospital | ||||||
Division name | Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 1 Hospital Drive | ||||||
TEL | 81211630 | ||||||
Homepage URL | |||||||
pluiepluie@gmail.com |
Sponsor | |
Institute | Neuvital Pte Ltd |
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Funding Source | |
Organization | Neuvital Pte Ltd |
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Category of Funding Organization | Other |
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Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019600 |
Research Plan | |
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Research case data | |
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