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"Magnetic Resonance Imaging Hysterosalpingography for the Integral Evaluation of the Infertile Patient." (HSG-RM)

Primary Purpose

Women Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
TC Virtual Hysterosalpingography
MRI Virtual Hysterosalpingography
Antimullerian Hormone dosing
Transvaginal Echography
Sponsored by
Diagnostico Maipu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Women Infertility focused on measuring Histerosalpingography, MRI, Magnetic Resonance Imaging, HSG, Diagnostico Maipu, Imaging, Carrascosa Patricia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Requested Virtual Hysterosalpingography.
  • Diagnosis of Infertility.
  • Informed Consent.

Exclusion Criteria:

  • Pregnancy at the time of examination.
  • Carriers of pacemaker devices.
  • Ferromagnetic elements incompatible with MRI.
  • Claustrophobia.
  • Allergy to iodine.

Sites / Locations

  • Diagnostico MaipuRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Label

Arm Description

This is a single arm open label study. Its procedures involve: Transvaginal Echography Conventional Virtual Histerosalpingography Virtual Histerosalpingography by MRI Blood draw for Antimullerian Hormone Dosing

Outcomes

Primary Outcome Measures

Tubal patency
Evaluation of the tubal patency between CT and MRI
Endocavitary pathology
Evaluation of endocavitary pathology between US, CT and MRI

Secondary Outcome Measures

Antral follicle count
Comparison of antral follicle count between US and MRI and its correlation with antimullerian hormone

Full Information

First Posted
March 20, 2015
Last Updated
May 31, 2016
Sponsor
Diagnostico Maipu
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1. Study Identification

Unique Protocol Identification Number
NCT02398630
Brief Title
"Magnetic Resonance Imaging Hysterosalpingography for the Integral Evaluation of the Infertile Patient."
Acronym
HSG-RM
Official Title
"Estudio de Histerosalpingografía Por Resonancia Magnética Para la evaluación Integral de la Paciente infértil."
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diagnostico Maipu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Abstract: Recent advances in reproductive medicine have generated a demand for more accurate imaging methods for identifying the specific cause of female infertility and other gynecologic disorders. Virtual hysterosalpingography is an emerging modality in which aspects of the established technique of hysterosalpingography are combined with the cutting-edge technology of multidetector computed tomography (CT) to allow a comprehensive and highly accurate evaluation of both the female reproductive system and the pelvic anatomy generally. Unlike ultrasonography (US) and magnetic resonance (MR) imaging, multidetector CT is capable of depicting both the external and internal surfaces of the uterus, fallopian tubes, and other pelvic organs, providing high-resolution data that are suitable for two- and three-dimensional reconstructions and virtual endoscopic views. Thus, virtual hysterosalpingography may prove to be superior to other noninvasive modalities for evaluating tubal patency. Moreover, in comparison with conventional hysterosalpingography, which may involve cervical clamping, virtual hysterosalpingography is painless. Because of the health risks associated with ionizing radiation, the use of another modality (eg, MR imaging, US) may be preferred if the presence of a focal uterine lesion is strongly suspected. However, virtual hysterosalpingography with multidetector CT may provide a diagnostic advantage in complex cases.
Detailed Description
Infertility is a common problem that affects one in six couples. It is defined as the inability to get pregnant after a reasonable time (12 months) of sex without using birth control measures. The causes of the increased prevalence of infertility are difficult to establish. This increase could be due to several factors such as the postponement of the time when it is decided to have children, alterations in semen quality, changes in sexual behavior, etc. The study of the infertile couple has always been focussed on different factors: ovulatory (20%), utero-tubal (30%) , the migration of sperm (10%) and male (30%). About 40% of all infertile couples exhibit a combination of factors and about 15% do not display any objective alteration leading to a definite diagnosis. During the last two decades major changes occurred in the approach to infertility. With the introduction of new assisted reproductive technologies, the development of molecular biology and novel diagnostic imaging methods, there have been major advances in the evaluation and treatment of couples considered infertile. Hysterosalpingography (HSG) is the useful imaging method for evaluating the fallopian tubes and uterine cavity. Scanning is performed in the follicular phase of the cycle and is carried out in an X-ray fluoroscopy. Indications for HSG have been reduced with the introduction of new diagnostic methods, actually being basically an essencial technique used in the study of the factors responsible for infertility as well as recurrent abortions. On the downside, exposure to radiation and use of impingement of the cervix during the procedure, with the possible complications mentioned. Due to technological advances, a new technique based on CT studies has been developed, and it is called virtual Hysterosalpingography (HSG-V). It is performed with a multislice CT scanner with high resolution and quality of images. It is a noninvasive study and needs none pinch the cervix. It has the ability to assess blockages and defects or other uterine and tubal problems, besides appreciating for abnormalities that may cause the inability of a couple to achieve pregnancy. Also reveals the organs of the pelvis in its entirety and fallopian tubes, and inside its walls. This helps to detect the presence of polyps, adhesions, fibroids, narrow tubes, or occupying lesions light. Compared with conventional HSG, the advantage is that it is non-invasive, painless and takes only a few seconds, conditions that provide women with greater comfort. Moreover, it provides the doctor with more complete information than the conventional method, because it provides two-dimensional and three-dimensional endoscopic images. Additionally, the radiation received by the patient is less than that required in the conventional study. Magnetic resonance imaging (MRI) of the female pelvis is the largest study performance evaluation of pelvic pathology (endometriosis, fibroids, adenomyosis, etc.). Contributing to this characteristics of being non-invasive and does not use ionizing radiation. It has high resolving power for the assessment of ovarian and uterine pathology, being especially useful for cases where ultrasound is inconclusive. It also plays a dual role in the case of uterine malformations: It allows the extension and/or confirmation of the ultrasound diagnosis and evaluates the associated malformations, mainly of the urinary system. Major limitations of the MRI are low availability, presence of a pacemaker or metallic foreign bodies. A relative advantage is its lower cost compared to the HSG-V, and lower cost if making multiple conventional studies. Current assessment of the patient with infertility involves several studies to determine the causative factor. The virtues of the MRI position it as an integrative alternative to conventional multi-modal methods in the study of the female pelvis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women Infertility
Keywords
Histerosalpingography, MRI, Magnetic Resonance Imaging, HSG, Diagnostico Maipu, Imaging, Carrascosa Patricia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Other
Arm Description
This is a single arm open label study. Its procedures involve: Transvaginal Echography Conventional Virtual Histerosalpingography Virtual Histerosalpingography by MRI Blood draw for Antimullerian Hormone Dosing
Intervention Type
Radiation
Intervention Name(s)
TC Virtual Hysterosalpingography
Other Intervention Name(s)
HSG-V
Intervention Description
Virtual hysterosalpingography: a new multidetector CT technique for evaluating the female reproductive system
Intervention Type
Other
Intervention Name(s)
MRI Virtual Hysterosalpingography
Other Intervention Name(s)
HSG-MRI
Intervention Description
Magnetic Resonance Imaging Virtual hysterosalpingography
Intervention Type
Other
Intervention Name(s)
Antimullerian Hormone dosing
Intervention Description
Blood Draw for Antimullerian Hormone dosing
Intervention Type
Other
Intervention Name(s)
Transvaginal Echography
Other Intervention Name(s)
TV-Echo
Intervention Description
Transvaginal Echography for evaluating the female reproductive system
Primary Outcome Measure Information:
Title
Tubal patency
Description
Evaluation of the tubal patency between CT and MRI
Time Frame
Six months
Title
Endocavitary pathology
Description
Evaluation of endocavitary pathology between US, CT and MRI
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Antral follicle count
Description
Comparison of antral follicle count between US and MRI and its correlation with antimullerian hormone
Time Frame
Six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Requested Virtual Hysterosalpingography. Diagnosis of Infertility. Informed Consent. Exclusion Criteria: Pregnancy at the time of examination. Carriers of pacemaker devices. Ferromagnetic elements incompatible with MRI. Claustrophobia. Allergy to iodine.
Facility Information:
Facility Name
Diagnostico Maipu
City
Vicente Lopez
State/Province
Buenos Aires
ZIP/Postal Code
1638
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano Starosiliz, Clinical Monitor
Phone
(54+11) 4837-7777
Ext
1352
Email
marianostarosiliz@diagnosticomaipu.com.ar
First Name & Middle Initial & Last Name & Degree
Patricia Carrascosa, MD
First Name & Middle Initial & Last Name & Degree
Javier Vallejos, MD
First Name & Middle Initial & Last Name & Degree
Carlos Capuñay, MD
First Name & Middle Initial & Last Name & Degree
Jimena Carpio, MD
First Name & Middle Initial & Last Name & Degree
Mariano Baronio, MD
First Name & Middle Initial & Last Name & Degree
Lorena Sarati, MD

12. IPD Sharing Statement

Links:
URL
http://www.diagnosticomaipu.com
Description
Diagnostico Maipu Website

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"Magnetic Resonance Imaging Hysterosalpingography for the Integral Evaluation of the Infertile Patient."

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