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

Women Infertility Clinical Trial

— HSG-RM  

Official title:

"Estudio de Histerosalpingografía Por Resonancia Magnética Para la evaluación Integral de la Paciente infértil."

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398630
• Other study ID #: HSG-RM
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2015
• Last updated: May 31, 2016
• Start date: September 2014

Study information

• Verified date: May 2016
• Source: Diagnostico Maipu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaArgentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Women Infertility

Intervention

Radiation:
• TC Virtual Hysterosalpingography
Virtual hysterosalpingography: a new multidetector CT technique for evaluating the female reproductive system

Other:
• MRI Virtual Hysterosalpingography
Magnetic Resonance Imaging Virtual hysterosalpingography
• Antimullerian Hormone dosing
Blood Draw for Antimullerian Hormone dosing
• Transvaginal Echography
Transvaginal Echography for evaluating the female reproductive system

Locations

Country	Name	City	State
Argentina	Diagnostico Maipu	Vicente Lopez	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Diagnostico Maipu

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tubal patency	Evaluation of the tubal patency between CT and MRI	Six months	No
Primary	Endocavitary pathology	Evaluation of endocavitary pathology between US, CT and MRI	Six months	No
Secondary	Antral follicle count	Comparison of antral follicle count between US and MRI and its correlation with antimullerian hormone	Six months	No

External Links

•   Diagnostico Maipu Website