Women InfertilityHSG-RMNCT02398630
"Magnetic Resonance Imaging Hysterosalpingography for the Integral Evaluation of the Infertile Patient."
A study testing TC Virtual Hysterosalpingography, MRI Virtual Hysterosalpingography and Antimullerian Hormone dosing in people with Women Infertility, run by Diagnostico Maipu at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Infertility
- What is being tested?
- TC Virtual Hysterosalpingography, MRI Virtual Hysterosalpingography and Antimullerian Hormone dosing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Requested Virtual Hysterosalpingography.
- Diagnosis of Infertility.
- Informed Consent.
Who cannot join
- Pregnancy at the time of examination.
- Carriers of pacemaker devices.
- Ferromagnetic elements incompatible with MRI.
- Claustrophobia.
- Allergy to iodine.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Diagnostico Maipu
Vicente López, Buenos Aires, 1638
Mariano Starosiliz, Clinical Monitor, (54+11) 4837-7777 ext. 1352, marianostarosiliz@diagnosticomaipu.com.ar
Patricia Carrascosa, MD
About this study
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.
Read the 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.
- Conditions
- Women Infertility
- Being tested
- TC Virtual Hysterosalpingography, MRI Virtual Hysterosalpingography, Antimullerian Hormone dosing, Transvaginal Echography
- Keywords
- Histerosalpingography, MRI, Magnetic Resonance Imaging, HSG, Diagnostico Maipu, Imaging, Carrascosa Patricia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC Virtual HysterosalpingographyRadiation
Also called HSG-V
Virtual hysterosalpingography: a new multidetector CT technique for evaluating the female reproductive system
MRI Virtual HysterosalpingographyOther
Also called HSG-MRI
Magnetic Resonance Imaging Virtual hysterosalpingography
Antimullerian Hormone dosingOther
Blood Draw for Antimullerian Hormone dosing
Transvaginal EchographyOther
Also called TV-Echo
Transvaginal Echography for evaluating the female reproductive system
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Other | 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 Receives: Radiation: TC Virtual Hysterosalpingography; Other: MRI Virtual Hysterosalpingography; Other: Antimullerian Hormone dosing; Other: Transvaginal Echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tubal patency
Evaluation of the tubal patency between CT and MRI
Measured: Six months
Endocavitary pathology
Evaluation of endocavitary pathology between US, CT and MRI
Measured: Six months
Secondary outcomes (1)
Antral follicle count
Comparison of antral follicle count between US and MRI and its correlation with antimullerian hormone
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diagnostico Maipu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398630
- Sponsor's protocol ID
- HSG-RM
- Acronym
- HSG-RM
- Status last verified
- May 2016
- First submitted
- 20 Mar 2015
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Estudio de Histerosalpingografía Por Resonancia Magnética Para la evaluación Integral de la Paciente infértil."
- ClinicalTrials.gov ID
- NCT02398630
- Acronym / sponsor ID
- HSG-RM / HSG-RM
- Conditions
- Women Infertility
- Keywords
- Histerosalpingography, MRI, Magnetic Resonance Imaging, HSG, Diagnostico Maipu, Imaging, Carrascosa Patricia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diagnostico MaipuUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Other | Radiation: TC Virtual Hysterosalpingography, Other: MRI Virtual Hysterosalpingography, Other: Antimullerian Hormone dosing, Other: Transvaginal EchographyThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Requested Virtual Hysterosalpingography.
- Diagnosis of Infertility.
- Informed Consent.
Key exclusion criteria (5 listed)
- Pregnancy at the time of examination.
- Carriers of pacemaker devices.
- Ferromagnetic elements incompatible with MRI.
- Claustrophobia.
- Allergy to iodine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC Virtual HysterosalpingographyAlso: HSG-VVirtual hysterosalpingography: a new multidetector CT technique for evaluating the female reproductive system | Radiation | Open Label |
| MRI Virtual HysterosalpingographyAlso: HSG-MRIMagnetic Resonance Imaging Virtual hysterosalpingography | Other | Open Label |
| Antimullerian Hormone dosingBlood Draw for Antimullerian Hormone dosing | Other | Open Label |
| Transvaginal EchographyAlso: TV-EchoTransvaginal Echography for evaluating the female reproductive system | Other | Open Label |
Primary outcome
Tubal patency
Time frame: Six months
Evaluation of the tubal patency between CT and MRI
Endocavitary pathology
Time frame: Six months
Evaluation of endocavitary pathology between US, CT and MRI
1 secondary outcome
Antral follicle count
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Diagnostico Maipu WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diagnostico Maipu
Vicente López, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC Virtual Hysterosalpingography, MRI Virtual Hysterosalpingography and Antimullerian Hormone dosing in people with Women Infertility, run by Diagnostico Maipu at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tubal patency (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.