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

Primary Purpose

Female Infertility

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiographic hysterosalpingography
Magnetic resonance imaging hysterosalpingography
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Female Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'imagerie médicale Hôpital Archet II

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Radiographic hysterosalpingography

Magnetic resonance imaging hysterosalpingography

Arm Description

Realisation in first: radiographic hysterosalpingographyresonance then imaging hysterosalpingography

Realisation in first : magnetic resonance imaging hysterosalpingography then a radiographic hysterosalpingography

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
October 5, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02108665
Brief Title
Magnetic Resonance Imaging (MRI) Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility
Official Title
Magnetic Resonance Imaging Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiographic hysterosalpingography
Arm Type
Other
Arm Description
Realisation in first: radiographic hysterosalpingographyresonance then imaging hysterosalpingography
Arm Title
Magnetic resonance imaging hysterosalpingography
Arm Type
Other
Arm Description
Realisation in first : magnetic resonance imaging hysterosalpingography then a radiographic hysterosalpingography
Intervention Type
Radiation
Intervention Name(s)
Radiographic hysterosalpingography
Intervention Type
Radiation
Intervention Name(s)
Magnetic resonance imaging hysterosalpingography
Primary Outcome Measure Information:
Title
Diagnostic performance of hystérosalpingo-MRI
Description
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.
Time Frame
one day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madleen CHASSANG, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'imagerie médicale Hôpital Archet II
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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

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