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

NCT ID: NCT02108665

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Female Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Radiographic hysterosalpingography

Realisation in first: radiographic hysterosalpingographyresonance then imaging hysterosalpingography

Group Type OTHER

Radiographic hysterosalpingography

Intervention Type RADIATION

Magnetic resonance imaging hysterosalpingography

Intervention Type RADIATION

Magnetic resonance imaging hysterosalpingography

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

Group Type OTHER

Radiographic hysterosalpingography

Intervention Type RADIATION

Magnetic resonance imaging hysterosalpingography

Intervention Type RADIATION

Interventions

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Radiographic hysterosalpingography

Intervention Type RADIATION

Magnetic resonance imaging hysterosalpingography

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madleen CHASSANG, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Service d'imagerie médicale Hôpital Archet II

Nice, , France

Site Status

Countries

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France

Other Identifiers

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11AOI07

Identifier Type: -

Identifier Source: org_study_id