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Magnetic Resonance Imaging (MRI) Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility

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ClinicalTrials.gov Identifier: NCT02108665
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.

Condition or disease Intervention/treatment Phase
Female Infertility Radiation: Radiographic hysterosalpingography Radiation: Magnetic resonance imaging hysterosalpingography Not Applicable

Detailed Description:

Infertility is a disease which affects around 15% of couples (one union of seven) and has been increasing for 10 years. Therefore, and due to the development of methods of medically assisted procreation, demand for infertility evaluation is steadily increasing.

The infertility evaluation always begins with an accurate history, coupled with a physical examination of both partners. Indeed, infertility of a couple is due to the female partner in about two thirds of cases, the male partner in the remaining third of cases. In women, the main observed causes are ovulatory function disorders (10 to 20%), tubal causes by proximal or distal occlusion (10%), uterine causes involving intra-uterine synechiae, leiomyomas, adenomyosis, mucosal polyps (5 %), inadequate cervical mucus or cervical stenosis , and peritoneal causes such as endometriosis and post-infectious or post-surgical peritubo-ovarian adhesions (20 %).

Medical imaging is one of the key methods to identify the different etiologies in men as in women. It will serve to clarify the etiology in question and assess the likelihood of subsequent pregnancy. The initial imaging assessment for infertility in any woman includes an endovaginal ultrasound examination and a hysterosalpingography (HSG) . The use of MRI is considered as a second line in the absence of definitive diagnosis or to establish a definitive diagnosis before considering a targeted therapy. Indeed the performance of MRI for the diagnosis of pelvic endometriosis or fibroids mapping are well established.

HSG is the imaging technique of choice to evaluate the morphology of the uterine cavity and tubal patency. But it has several important limitations. Firstly it is an imaging method that uses x-rays and therefore delivers irradiation to the gynecological organs. Moreover, it does not allow a precise exploration of the entire abdomen and pelvis: therefore, the physician cannot have a complete assessment of the etiologies of infertility with HSG. Finally, it has a very good specificity but a relatively low sensitivity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility
Actual Study Start Date : January 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2017

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Arms and Interventions
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Arm Intervention/treatment
Radiographic hysterosalpingography
Realisation in first: radiographic hysterosalpingographyresonance then imaging hysterosalpingography
 Radiation: Radiographic hysterosalpingography
Radiation: Magnetic resonance imaging hysterosalpingography
Magnetic resonance imaging hysterosalpingography
Realisation in first : magnetic resonance imaging hysterosalpingography then a radiographic hysterosalpingography
 Radiation: Radiographic hysterosalpingography
Radiation: Magnetic resonance imaging hysterosalpingography


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic performance of hystérosalpingo-MRI [ Time Frame: one day ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contraindication to magnetic resonance imaging hysterosalpingography Contraindication to radiographic hysterosalpingography

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108665


Locations
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France
Service d'imagerie médicale Hôpital Archet II
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Madleen CHASSANG, MD Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02108665    
Other Study ID Numbers: 11AOI07
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Infertility
Infertility, Female