Infertility,NCT02710006
Automatic Volume Calculations During Three-dimensional Sonohysterography.
A study testing Sonohysterography in people with Infertility, and Abortions, Spontaneous, Habitual, run by Ludwin & Ludwin Gynecology, Private Medical Center at 1 site in Poland.
Trial summary
The purpose of this trial is to evaluate the feasibility and reliability of automatic volume calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and uterine cavity will be acquired during three-dimensional ultrasonography and sonohysterography. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility,, Abortions, Spontaneous, Habitual
- What is being tested?
- Sonohysterography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Sep 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 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertility (12 months trying to conceive without success) and/or two previous miscarriages
Who cannot join
- unknown pregnancy (ultrasound examination)
- menopause
- precancerous conditions and cancers of female genital tract
- refused consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Ludwin & Ludwin Gynecology, Specialist Medical Practice Artur Ludwin
Krakow, Malopolska, 31 521
About this study
Official title: Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.
The purpose of this trial is to evaluate the feasibility and reliability of automatic volume calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and uterine cavity will be acquired during three-dimensional ultrasonography and sonohysterography. After that independent observers will measure offline the uterine cavity volume using automatic volume calculation using SonoAVC general software, and VOCAL software.
Read the detailed description
INTRODUCTION
The uterus is one of key organs in reproduction and fetal development. A distorted shape and size of uterine cavity may to have significant impact on the reproductive failures (Chan et al., 2011; Saravelos et al., 2008). Current definitions and classification for uterine morphology and its congenital malformation are still controversial (Grimbizis et al., 2013; 2015; Ludwin and Ludwin, 2015a, b). This is an important barrier for studies evaluating the effectiveness of interventions for women with such conditions (Ludwin et al., 2015 a, b).
The uterine cavity volume is a specific feature of each individual uterus, and together with shape of uterine cavity may play one of the crucial roles in etiology of reproductive failures. To the investigators' knowledge the uterine cavity volume has never been studied in this context (Ludwin et al., 2016).
Recently, the technique of uterine cavity imaging, volume estimation, and quantification of deformity degree using automatic volume calculation (called SonoHysteroAVC; using SonoAVC software; GE Medical Systems, Zipf, Austria) during three-dimensional sonohysterography has been described (Ludwin et al., 2016). Uterine volume estimation is also potentially possible using Virtual Organ Computer-aided AnaLysis (VOCAL™; GE Medical Systems, Zipf, Austria), as for endometrial volume calculation (Martins et al., 2011).
The investigators believe that SonoHysteroAVC technique might improve the knowledge about uterine anatomy, the diagnostic accuracy of uterine cavity shape imaging, and the management of women with different morphological shapes of the uterine cavity. (Ludwin et al., 2016).
AIMS AND HYPOTHESES
Objective: to assess the inter-observer reliability of measuring the uterine cavity volume by automatic volume calculation.
Hypothesis: inter-observer reliability of the uterine cavity volume estimation using automatic volume calculation is very good.
Additional objective: to compare SonoAVC with VOCAL in uterine cavity volume estimation
DESIGN AND PATIENTS Design:Described elsewhere Setting:Described elsewhere Patients: Described elsewhere Inclusion criteria: Described elsewhere Exclusion criteria: Described elsewhere
Sample size:
The reliability estimates of uterine cavity automatic volume estimation are unknown. The feasibility of automatic volume calculation in deferent uterine condition also is unknown.
The investigators assumed that 100 subjects would be sufficient to obtain precise reliability coefficients (Streiner and Kottner, 2014), and 30 participants is minimal sample size for the feasibility study.
Interventions: Repeated three-dimensional sonohysterography (3D-SIS).
Data acquisition: two 3D data-sets of 3D-SIS per participant (observer 0; Obs0).
Analysis: Observer A (ObsA) will analyze the 1st data-set twice and the 2nd data-set once. Observer B (ObsB) will analyze the 2nd data-set once.
Comparisons:
ObsA-Dataset1 (1st analysis) vs. ObsA-Dataset1 (2nd analysis) to determine of repeatability ObsA-Dataset1 vs. ObsA-Dataset2 to determine variability caused by repeating the procedure ObsA-Dataset2 vs. ObsB-Dataset2 to determine inter-observer variability by reading ObsA-Dataset1 vs. ObsB-Dataset2 to determine inter-observer variability caused by repeating the exam
Outcomes:
- The concordance correlation coefficient ii) Limits of agreement (LoA) iii) Time needed for acquisition iv) Time needed for analysis
Additional aim:
SonoAVC vs VOCAL (reproducibility and time needed)
Data processing and analysis: The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data.
Consent: All subjects will be given detailed explanation of the study and a written consent form will be signed by the patient and retained in the investigators' confidential records.
- Conditions
- Infertility,, Abortions, Spontaneous, Habitual
- Being tested
- Sonohysterography
- Keywords
- Uterus, Ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonohysterographyProcedure or surgery
Also called Saline infusion sonography
Sonohysterography, also known as saline infusion sonography, is a special, minimally invasive ultrasound technique. Sonohysterography is a technique in which fluid is injected through the cervix into the uterus, and ultrasound is used to. It provides pictures of the inside of a woman's uterus. Three-dimensional sonohysterography is based on volumetric scanning of uterus and its cavity during saline infusion.
| Study group | Role | What they receive |
|---|---|---|
| SonoHysteroAVC | Experimental | Three-dimensional sonohysterography is the first point for uterine cavity volume estimation, and it is going to be performed in all participants. The investigators are going to fill the uterine cavity twice by saline solution during single sonohysterography procedure, and acquise the volumetric datasets of uterus for offline analysis. The 3D dataset containing the entire uterine cavity will by analyzed using a personal computer and/or the ultrasound machine with specific softwere. Receives: Procedure: Sonohysterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance correlation coefficient in uterine cavity automated volume calculation
the concordance correlation coefficient measures the agreement between two variables to evaluate reliability
Measured: up to 12 months
Limits of agreement (LoA) in uterine cavity volume estimation
Limits of agreement are an estimate of the interval within which a proportion of the differences between measurements lie.
Measured: up to 12 months
Time needed for acquisition
Time needed for performing of three-dimensional sonohysterography and for uterine cavity 3D dataset acquisition (time of real-time three-dimensional sonohysterography)
Measured: up to 12 months
Time needed for uterine cavity volume analysis
Time needed for performing of uterine cavity volume calculation in offline analysis
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Infertility,Studies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwin & Ludwin Gynecology, Private Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, University of Sao Paulo
- Responsible party
- Principal investigator, Artur Ludwin, Ludwin & Ludwin Gynecology, Private Medical Center
- Investigators
- Artur Ludwin, MD, PhD, Principal investigator, Ludwin & Ludwin Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710006
- Sponsor's protocol ID
- 2/KBL/OIL/2016
- Status last verified
- Sep 2016
- First submitted
- 6 Mar 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ludwin A, Ludwin I. Comparison of the ESHRE-ESGE and ASRM classifications of Mullerian duct anomalies in everyday practice. Hum Reprod. 2015 Mar;30(3):569-80. doi: 10.1093/humrep/deu344. Epub 2014 Dec 22.
PubMed 25534461Ludwin A, Ludwin I. Diagnostic rate and accuracy of the ESHRE-ESGE classification for septate uterus and other common uterine malformations: why do we not see that the Emperor is naked? Ultrasound Obstet Gynecol. 2015 Nov;46(5):634-6. doi: 10.1002/uog.14941. No abstract available.
PubMed 26525503Ludwin A, Ludwin I, Kudla M, Pitynski K, Banas T, Jach R, Knafel A. Diagnostic accuracy of three-dimensional sonohysterography compared with office hysteroscopy and its interrater/intrarater agreement in uterine cavity assessment after hysteroscopic metroplasty. Fertil Steril. 2014 May;101(5):1392-9. doi: 10.1016/j.fertnstert.2014.01.039. Epub 2014 Feb 26.
PubMed 24581576Martins WP, Raine-Fenning NJ, Leite SP, Ferriani RA, Nastri CO. A standardized measurement technique may improve the reliability of measurements of endometrial thickness and volume. Ultrasound Obstet Gynecol. 2011 Jul;38(1):107-15. doi: 10.1002/uog.9016. Epub 2011 Apr 28.
PubMed 21465609Coelho Neto MA, Roncato P, Nastri CO, Martins WP. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2015 Jul;46(1):14-20. doi: 10.1002/uog.14654. Epub 2015 Jun 4.
PubMed 25175693Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
PubMed 21830244Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brolmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14.
PubMed 23771171Grimbizis GF, Di Spiezio Sardo A, Saravelos SH, Gordts S, Exacoustos C, Van Schoubroeck D, Bermejo C, Amso NN, Nargund G, Timmerman D, Athanasiadis A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Tarlatzis B, Farquharson R, Gianaroli L, Campo R. The Thessaloniki ESHRE/ESGE consensus on diagnosis of female genital anomalies. Hum Reprod. 2016 Jan;31(1):2-7. doi: 10.1093/humrep/dev264. Epub 2015 Nov 4.
PubMed 26537921Ludwin A, Ludwin I, Kudla M, Kottner J. Reliability of the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy and American Society for Reproductive Medicine classification systems for congenital uterine anomalies detected using three-dimensional ultrasonography. Fertil Steril. 2015 Sep;104(3):688-97.e8. doi: 10.1016/j.fertnstert.2015.06.019. Epub 2015 Jul 7.
PubMed 26158905Ludwin A, Martins WP, Ludwin I. Uterine cavity imaging, volume estimation and quantification of degree of deformity using automatic volume calculation: description of technique. Ultrasound Obstet Gynecol. 2017 Jul;50(1):138-140. doi: 10.1002/uog.15890. Epub 2017 May 28. No abstract available.
PubMed 26919726Streiner DL, Kottner J. Recommendations for reporting the results of studies of instrument and scale development and testing. J Adv Nurs. 2014 Sep;70(9):1970-1979. doi: 10.1111/jan.12402. Epub 2014 Mar 30.
PubMed 24684713
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.
- ClinicalTrials.gov ID
- NCT02710006
- Acronym / sponsor ID
- 2/KBL/OIL/2016
- Conditions
- Infertility,, Abortions, Spontaneous, Habitual
- Keywords
- Uterus, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ludwin & Ludwin Gynecology, Private Medical CenterUniversity, hospital or other
- Collaborators
- Jagiellonian University, University of Sao Paulo
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Mar 2016 (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.
The purpose of this trial is to evaluate the feasibility and reliability of automatic volume calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and uterine cavity will be acquired during three-dimensional ultrasonography and sonohysterography. After that independent observers will measure offline the uterine cavity volume using automatic volume calculation using SonoAVC general software, and VOCAL software.
Detailed description
INTRODUCTION
The uterus is one of key organs in reproduction and fetal development. A distorted shape and size of uterine cavity may to have significant impact on the reproductive failures (Chan et al., 2011; Saravelos et al., 2008). Current definitions and classification for uterine morphology and its congenital malformation are still controversial (Grimbizis et al., 2013; 2015; Ludwin and Ludwin, 2015a, b). This is an important barrier for studies evaluating the effectiveness of interventions for women with such conditions (Ludwin et al., 2015 a, b).
The uterine cavity volume is a specific feature of each individual uterus, and together with shape of uterine cavity may play one of the crucial roles in etiology of reproductive failures. To the investigators' knowledge the uterine cavity volume has never been studied in this context (Ludwin et al., 2016).
Recently, the technique of uterine cavity imaging, volume estimation, and quantification of deformity degree using automatic volume calculation (called SonoHysteroAVC; using SonoAVC software; GE Medical Systems, Zipf, Austria) during three-dimensional sonohysterography has been described (Ludwin et al., 2016). Uterine volume estimation is also potentially possible using Virtual Organ Computer-aided AnaLysis (VOCAL™; GE Medical Systems, Zipf, Austria), as for endometrial volume calculation (Martins et al., 2011).
The investigators believe that SonoHysteroAVC technique might improve the knowledge about uterine anatomy, the diagnostic accuracy of uterine cavity shape imaging, and the management of women with different morphological shapes of the uterine cavity. (Ludwin et al., 2016).
AIMS AND HYPOTHESES
Objective: to assess the inter-observer reliability of measuring the uterine cavity volume by automatic volume calculation.
Hypothesis: inter-observer reliability of the uterine cavity volume estimation using automatic volume calculation is very good.
Additional objective: to compare SonoAVC with VOCAL in uterine cavity volume estimation
DESIGN AND PATIENTS Design:Described elsewhere Setting:Described elsewhere Patients: Described elsewhere Inclusion criteria: Described elsewhere Exclusion criteria: Described elsewhere
Sample size:
The reliability estimates of uterine cavity automatic volume estimation are unknown. The feasibility of automatic volume calculation in deferent uterine condition also is unknown.
The investigators assumed that 100 subjects would be sufficient to obtain precise reliability coefficients (Streiner and Kottner, 2014), and 30 participants is minimal sample size for the feasibility study.
Interventions: Repeated three-dimensional sonohysterography (3D-SIS).
Data acquisition: two 3D data-sets of 3D-SIS per participant (observer 0; Obs0).
Analysis: Observer A (ObsA) will analyze the 1st data-set twice and the 2nd data-set once. Observer B (ObsB) will analyze the 2nd data-set once.
Comparisons:
ObsA-Dataset1 (1st analysis) vs. ObsA-Dataset1 (2nd analysis) to determine of repeatability ObsA-Dataset1 vs. ObsA-Dataset2 to determine variability caused by repeating the procedure ObsA-Dataset2 vs. ObsB-Dataset2 to determine inter-observer variability by reading ObsA-Dataset1 vs. ObsB-Dataset2 to determine inter-observer variability caused by repeating the exam
Outcomes:
- The concordance correlation coefficient ii) Limits of agreement (LoA) iii) Time needed for acquisition iv) Time needed for analysis
Additional aim:
SonoAVC vs VOCAL (reproducibility and time needed)
Data processing and analysis: The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data.
Consent: All subjects will be given detailed explanation of the study and a written consent form will be signed by the patient and retained in the investigators' confidential records.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SonoHysteroAVC | Experimental | Procedure: SonohysterographyThree-dimensional sonohysterography is the first point for uterine cavity volume estimation, and it is going to be performed in all participants. The investigators are going to fill the uterine cavity twice by saline solution during single sonohysterography procedure, and acquise the volumetric datasets of uterus for offline analysis. The 3D dataset containing the entire uterine cavity will by analyzed using a personal computer and/or the ultrasound machine with specific softwere. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertility (12 months trying to conceive without success) and/or two previous miscarriages
Key exclusion criteria (4 listed)
- unknown pregnancy (ultrasound examination)
- menopause
- precancerous conditions and cancers of female genital tract
- refused consent
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 |
|---|---|---|
| SonohysterographyAlso: Saline infusion sonographySonohysterography, also known as saline infusion sonography, is a special, minimally invasive ultrasound technique. Sonohysterography is a technique in which fluid is injected through the cervix into the uterus, and ultrasound is used to. It provides pictures of the inside of a woman's uterus. Three-dimensional sonohysterography is based on volumetric scanning of uterus and its cavity during saline infusion. | Procedure or surgery | SonoHysteroAVC |
Primary outcome
Concordance correlation coefficient in uterine cavity automated volume calculation
Time frame: up to 12 months
the concordance correlation coefficient measures the agreement between two variables to evaluate reliability
Limits of agreement (LoA) in uterine cavity volume estimation
Time frame: up to 12 months
Limits of agreement are an estimate of the interval within which a proportion of the differences between measurements lie.
Time needed for acquisition
Time frame: up to 12 months
Time needed for performing of three-dimensional sonohysterography and for uterine cavity 3D dataset acquisition (time of real-time three-dimensional sonohysterography)
Time needed for uterine cavity volume analysis
Time frame: up to 12 months
Time needed for performing of uterine cavity volume calculation in offline analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 25534461Ludwin A, Ludwin I. Comparison of the ESHRE-ESGE and ASRM classifications of Mullerian duct anomalies in everyday practice. Hum Reprod. 2015 Mar;30(3):569-80. doi: 10.1093/humrep/deu344. Epub 2014 Dec 22.
- Background: PubMed 26525503Ludwin A, Ludwin I. Diagnostic rate and accuracy of the ESHRE-ESGE classification for septate uterus and other common uterine malformations: why do we not see that the Emperor is naked? Ultrasound Obstet Gynecol. 2015 Nov;46(5):634-6. doi: 10.1002/uog.14941. No abstract available.
- Background: PubMed 24581576Ludwin A, Ludwin I, Kudla M, Pitynski K, Banas T, Jach R, Knafel A. Diagnostic accuracy of three-dimensional sonohysterography compared with office hysteroscopy and its interrater/intrarater agreement in uterine cavity assessment after hysteroscopic metroplasty. Fertil Steril. 2014 May;101(5):1392-9. doi: 10.1016/j.fertnstert.2014.01.039. Epub 2014 Feb 26.
- Background: PubMed 21465609Martins WP, Raine-Fenning NJ, Leite SP, Ferriani RA, Nastri CO. A standardized measurement technique may improve the reliability of measurements of endometrial thickness and volume. Ultrasound Obstet Gynecol. 2011 Jul;38(1):107-15. doi: 10.1002/uog.9016. Epub 2011 Apr 28.
- Background: PubMed 25175693Coelho Neto MA, Roncato P, Nastri CO, Martins WP. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2015 Jul;46(1):14-20. doi: 10.1002/uog.14654. Epub 2015 Jun 4.
- Background: PubMed 21830244Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
- Background: PubMed 23771171Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brolmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14.
- Background: PubMed 26537921Grimbizis GF, Di Spiezio Sardo A, Saravelos SH, Gordts S, Exacoustos C, Van Schoubroeck D, Bermejo C, Amso NN, Nargund G, Timmerman D, Athanasiadis A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Tarlatzis B, Farquharson R, Gianaroli L, Campo R. The Thessaloniki ESHRE/ESGE consensus on diagnosis of female genital anomalies. Hum Reprod. 2016 Jan;31(1):2-7. doi: 10.1093/humrep/dev264. Epub 2015 Nov 4.
- Background: PubMed 26158905Ludwin A, Ludwin I, Kudla M, Kottner J. Reliability of the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy and American Society for Reproductive Medicine classification systems for congenital uterine anomalies detected using three-dimensional ultrasonography. Fertil Steril. 2015 Sep;104(3):688-97.e8. doi: 10.1016/j.fertnstert.2015.06.019. Epub 2015 Jul 7.
- Background: PubMed 26919726Ludwin A, Martins WP, Ludwin I. Uterine cavity imaging, volume estimation and quantification of degree of deformity using automatic volume calculation: description of technique. Ultrasound Obstet Gynecol. 2017 Jul;50(1):138-140. doi: 10.1002/uog.15890. Epub 2017 May 28. No abstract available.
- Background: PubMed 24684713Streiner DL, Kottner J. Recommendations for reporting the results of studies of instrument and scale development and testing. J Adv Nurs. 2014 Sep;70(9):1970-1979. doi: 10.1111/jan.12402. Epub 2014 Mar 30.
- Individual participant dataSharing planned: No
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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.
Artur Ludwin, MD, PhD principal investigator
Ludwin & Ludwin Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonohysterography in people with Infertility, and Abortions, Spontaneous, Habitual, run by Ludwin & Ludwin Gynecology, Private Medical Center at 1 site in Poland.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Sep 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance correlation coefficient in uterine cavity automated volume calculation (time frame: up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710006, which also lists 11 linked publications.
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 7 Sep 2016.