Women Infertility Clinical Trial
Official title:
"Estudio de Histerosalpingografía Por Resonancia Magnética Para la evaluación Integral de la Paciente infértil."
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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