Magnetic Resonance Imaging (MRI) Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility
Magnetic Resonance Imaging Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility
1 other identifier
interventional
40
1 country
1
Brief Summary
The main objective of this study is to compare the data of Hystérosalpingo-MRI with intra cavitary injection of diluted gadolinium salts with the classic hysterography, which allows to realize at once with no irradiating examination, a complete assessment of the female infertility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMarch 31, 2026
March 1, 2026
3.2 years
April 7, 2014
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance of hystérosalpingo-MRI
To assess the diagnostic performance of hystérosalpingo-MRI by its sensitivity, specificity, negative predictive value, positive predictive value. To determine uterine cavity abnormality by the presence of the following abnormalities: synechiae, polyp, intra cavitary myoma, adenomyosis, uterine malformation.
one day
Study Arms (2)
Radiographic hysterosalpingography
OTHERRealisation in first: radiographic hysterosalpingographyresonance then imaging hysterosalpingography
Magnetic resonance imaging hysterosalpingography
OTHERRealisation in first : magnetic resonance imaging hysterosalpingography then a radiographic hysterosalpingography
Interventions
Eligibility Criteria
You may qualify if:
- Patient who a pelvic MRI and an Hysterography, part of an infertility assessment, have been prescribed by a gynecologist physician in Nice University Hospital.
- Informed consent signed Patient with social insurance Age \> 18
You may not qualify if:
- Contraindication to magnetic resonance imaging hysterosalpingography Contraindication to radiographic hysterosalpingography
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'imagerie médicale Hôpital Archet II
Nice, 06000, France
Related Publications (1)
Volondat M, Fontas E, Delotte J, Fatfouta I, Chevallier P, Chassang M. Magnetic resonance hysterosalpingography in diagnostic work-up of female infertility - comparison with conventional hysterosalpingography: a randomised study. Eur Radiol. 2019 Feb;29(2):501-508. doi: 10.1007/s00330-018-5572-2. Epub 2018 Jul 4.
PMID: 29974219RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madleen CHASSANG, MD
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 9, 2014
Study Start
January 1, 2013
Primary Completion
April 1, 2016
Study Completion
August 1, 2017
Last Updated
March 31, 2026
Record last verified: 2026-03