InfertilityNCT03610009
2D Versus SonoAVC Scanning in High Responders
A study testing 2D ultrasound and SonoAVC in people with Infertility, run by Eugonia at 1 site in Greece.
Trial summary
Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). The aim of this study is to evaluate the effect of timing oocyte maturation and egg collection on the basis of follicular measurements made… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- 2D ultrasound and SonoAVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2018to 30 Sep 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- AMH >= 3ng/ml
- at least 14 follicles =>11 mm diameter on final day of stimulation
- undergoing GnRH antagonist protocol
- administered GnRH agonist to trigger final oocyte maturation
Who cannot join
- poor responders
- hCG injection to trigger final oocyte maturation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Versus Automated Measurements of Ovarian Follicle Diameter in High Responding Patients With GnRH Agonist Triggering of Final Oocyte Maturation
Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). The aim of this study is to evaluate the effect of timing oocyte maturation and egg collection on the basis of follicular measurements made automatically with Sono Automated Volume Calculation (SonoAVC) against those made with conventional 2D ultrasound in relation to the number of mature oocytes collected.
This study will take place in women undergoing IVF who are high responders (>=14 follicles>=11mm) and hence at risk for developing ovarian hyperstimulation syndrome (OHSS), treated with a GnRH antagonist protocol and administered GnRH agonist to trigger final oocyte maturation.
Read the detailed description
Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). Accurate assessment of the size of follicles is important for the timing of oocyte maturation and subsequent oocyte retrieval.
Serial assessment of follicle number and size is used routinely to assess the response to ovarian stimulation during assisted reproduction treatment (ART). Two-dimensional (2D) ultrasound is used to identify and scroll through each ovary while the observer quantifies the number of follicles present. An objective assessment of the size of the larger follicles, commonly those measuring >10 mm, is then made through a series of 2D measurements of their perceived mean diameter.
Sono Automated Volume Calculation (SonoAVC; GE Medical Systems) is a new software program that can be applied to datasets acquired with use of threedimensional (3D) ultrasound. It individually identifies and quantifies the size of any hypoechoic region within these 3D datasets, providing an automatic estimation of their absolute dimensions and volume. SonoAVC is an ideal and, potentially, a clinically important tool for the assessment and measurement of follicles during controlled ovarian stimulation because each hypoechoic area is individually color coded, thereby eliminating the possibility of measuring the same follicle more than once.
In women with high ovarian response to gonadotrophin stimulation, the accurate measurement of the number and size of follicles present in hyperstimulated ovaries is a challenge for clinicians and ultrasonographers.
The aim of this study is to evaluate the effect of timing final oocyte maturation trigger and egg collection on the basis of follicular measurements made automatically with SonoAVC against those made with conventional 2D ultrasound in relation to the number of mature oocytes collected. This study will include women undergoing ART who are high responders (presence of =>14 follicles>=11mm) and hence at risk for developing ovarian hyperstimulation syndrome (OHSS), treated with a GnRH antagonist protocol and are administered GnRH agonist to trigger final oocyte maturation. All resulting embryos (blastocysts) will be cryopreserved and transferred in a subsequent frozen cycle.
- Conditions
- Infertility
- Being tested
- 2D ultrasound, SonoAVC
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D ultrasoundDevice
The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of conventional two-dimensional (2D) ultrasound.
SonoAVCDevice
The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of SonoAVC.
| Study group | Role | What they receive |
|---|---|---|
| 2D ultrasound | Active comparator | Two-dimensional (2D) ultrasound is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation. Receives: Device: 2D ultrasound |
| SonoAVC | Active comparator | SonoAVC is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation. Receives: Device: SonoAVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes
The number of mature (metaphase-II) oocytes retrieved
Measured: Day of oocyte retrieval
Secondary outcomes (8)
Number of oocytes retrieved
Total number of oocytes retrieved
Measured: Day of oocyte retrieval
Oocyte maturation rate
Percentage of mature oocytes/total number of oocytes
Measured: Day of oocyte retrieval
Oocyte retrieval rate
Percentage of oocyte retrieved/number of follicles aspirated
Measured: Day of oocyte retrieval
Number of fertilised oocytes
Number of fertilised oocytes displaying 2 pronuclei and 2 polar bodies
Measured: 1 day post oocyte retrieval
Fertilisation rate
Percentage fertilised oocytes/oocytes inseminated
Measured: 1 day post oocyte retrieval
Number of blastocysts
Number of embryos reaching the blastocyst stage
Measured: 5 days post oocyte retrieval
Days of stimulation
Number of days recFSH is administered
Measured: 10-15 days after menses
Total dose of recFSH
Total dose of recFSH administered during the ovarian stimulation period
Measured: 10-15 days after menses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Jan 2019
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Follicle development in women undergoing IVF will be monitored either by conventional 2D ultrasound or SonoAVC.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tryfon Lainas, PhD, Study director, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610009
- Sponsor's protocol ID
- SonoAVC
- Status last verified
- Feb 2019
- First submitted
- 24 Jul 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raine-Fenning N, Deb S, Jayaprakasan K, Clewes J, Hopkisson J, Campbell B. Timing of oocyte maturation and egg collection during controlled ovarian stimulation: a randomized controlled trial evaluating manual and automated measurements of follicle diameter. Fertil Steril. 2010 Jun;94(1):184-8. doi: 10.1016/j.fertnstert.2009.02.063. Epub 2009 Apr 1.
PubMed 19342014Lamazou F, Arbo E, Salama S, Grynberg M, Frydman R, Fanchin R. Reliability of automated volumetric measurement of multiple growing follicles in controlled ovarian hyperstimulation. Fertil Steril. 2010 Nov;94(6):2172-6. doi: 10.1016/j.fertnstert.2010.01.062. Epub 2010 Mar 12.
PubMed 20226448Salama S, Arbo E, Lamazou F, Levailllant JM, Frydman R, Fanchin R. Reproducibility and reliability of automated volumetric measurement of single preovulatory follicles using SonoAVC. Fertil Steril. 2010 Apr;93(6):2069-73. doi: 10.1016/j.fertnstert.2008.12.115. Epub 2009 Apr 1.
PubMed 19342038Ata B, Seyhan A, Reinblatt SL, Shalom-Paz E, Krishnamurthy S, Tan SL. Comparison of automated and manual follicle monitoring in an unrestricted population of 100 women undergoing controlled ovarian stimulation for IVF. Hum Reprod. 2011 Jan;26(1):127-33. doi: 10.1093/humrep/deq320. Epub 2010 Nov 26.
PubMed 21112951Rodriguez-Fuentes A, Hernandez J, Garcia-Guzman R, Chinea E, Iaconianni L, Palumbo A. Prospective evaluation of automated follicle monitoring in 58 in vitro fertilization cycles: follicular volume as a new indicator of oocyte maturity. Fertil Steril. 2010 Feb;93(2):616-20. doi: 10.1016/j.fertnstert.2009.02.058. Epub 2009 Apr 18.
PubMed 19376513Revelli A, Martiny G, Delle Piane L, Benedetto C, Rinaudo P, Tur-Kaspa I. A critical review of bi-dimensional and three-dimensional ultrasound techniques to monitor follicle growth: do they help improving IVF outcome? Reprod Biol Endocrinol. 2014 Nov 24;12:107. doi: 10.1186/1477-7827-12-107.
PubMed 25420733Deb S, Campbell BK, Clewes JS, Raine-Fenning NJ. Quantitative analysis of antral follicle number and size: a comparison of two-dimensional and automated three-dimensional ultrasound techniques. Ultrasound Obstet Gynecol. 2010 Mar;35(3):354-60. doi: 10.1002/uog.7505.
PubMed 20069654Deutch TD, Joergner I, Matson DO, Oehninger S, Bocca S, Hoenigmann D, Abuhamad A. Automated assessment of ovarian follicles using a novel three-dimensional ultrasound software. Fertil Steril. 2009 Nov;92(5):1562-8. doi: 10.1016/j.fertnstert.2008.08.102. Epub 2008 Oct 19.
PubMed 18937942Vandekerckhove F, Bracke V, De Sutter P. The Value of Automated Follicle Volume Measurements in IVF/ICSI. Front Surg. 2014 May 28;1:18. doi: 10.3389/fsurg.2014.00018. eCollection 2014.
PubMed 25593942Pan P, Chen X, Li Y, Zhang Q, Zhao X, Bodombossou-Djobo MM, Yang D. Comparison of manual and automated measurements of monodominant follicle diameter with different follicle size in infertile patients. PLoS One. 2013 Oct 10;8(10):e77095. doi: 10.1371/journal.pone.0077095. eCollection 2013.
PubMed 24130840Raine-Fenning N, Jayaprakasan K, Chamberlain S, Devlin L, Priddle H, Johnson I. Automated measurements of follicle diameter: a chance to standardize? Fertil Steril. 2009 Apr;91(4 Suppl):1469-72. doi: 10.1016/j.fertnstert.2008.07.1719. Epub 2008 Oct 18.
PubMed 18930205Raine-Fenning N, Jayaprakasan K, Clewes J, Joergner I, Bonaki SD, Chamberlain S, Devlin L, Priddle H, Johnson I. SonoAVC: a novel method of automatic volume calculation. Ultrasound Obstet Gynecol. 2008 Jun;31(6):691-6. doi: 10.1002/uog.5359.
PubMed 18484679Broekmans FJ, de Ziegler D, Howles CM, Gougeon A, Trew G, Olivennes F. The antral follicle count: practical recommendations for better standardization. Fertil Steril. 2010 Aug;94(3):1044-51. doi: 10.1016/j.fertnstert.2009.04.040. Epub 2009 Jul 8.
PubMed 19589513Soldevila PN, Carreras O, Tur R, Coroleu B, Barri PN. Sonographic assessment of ovarian reserve. Its correlation with outcome of in vitro fertilization cycles. Gynecol Endocrinol. 2007 Apr;23(4):206-12. doi: 10.1080/09513590701253776.
PubMed 17505940
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Versus Automated Measurements of Ovarian Follicle Diameter in High Responding Patients With GnRH Agonist Triggering of Final Oocyte Maturation
- ClinicalTrials.gov ID
- NCT03610009
- Acronym / sponsor ID
- SonoAVC
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 1 Aug 2018 (actual)
- 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.
Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). The aim of this study is to evaluate the effect of timing oocyte maturation and egg collection on the basis of follicular measurements made automatically with Sono Automated Volume Calculation (SonoAVC) against those made with conventional 2D ultrasound in relation to the number of mature oocytes collected.
This study will take place in women undergoing IVF who are high responders (>=14 follicles>=11mm) and hence at risk for developing ovarian hyperstimulation syndrome (OHSS), treated with a GnRH antagonist protocol and administered GnRH agonist to trigger final oocyte maturation.
Detailed description
Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). Accurate assessment of the size of follicles is important for the timing of oocyte maturation and subsequent oocyte retrieval.
Serial assessment of follicle number and size is used routinely to assess the response to ovarian stimulation during assisted reproduction treatment (ART). Two-dimensional (2D) ultrasound is used to identify and scroll through each ovary while the observer quantifies the number of follicles present. An objective assessment of the size of the larger follicles, commonly those measuring >10 mm, is then made through a series of 2D measurements of their perceived mean diameter.
Sono Automated Volume Calculation (SonoAVC; GE Medical Systems) is a new software program that can be applied to datasets acquired with use of threedimensional (3D) ultrasound. It individually identifies and quantifies the size of any hypoechoic region within these 3D datasets, providing an automatic estimation of their absolute dimensions and volume. SonoAVC is an ideal and, potentially, a clinically important tool for the assessment and measurement of follicles during controlled ovarian stimulation because each hypoechoic area is individually color coded, thereby eliminating the possibility of measuring the same follicle more than once.
In women with high ovarian response to gonadotrophin stimulation, the accurate measurement of the number and size of follicles present in hyperstimulated ovaries is a challenge for clinicians and ultrasonographers.
The aim of this study is to evaluate the effect of timing final oocyte maturation trigger and egg collection on the basis of follicular measurements made automatically with SonoAVC against those made with conventional 2D ultrasound in relation to the number of mature oocytes collected. This study will include women undergoing ART who are high responders (presence of =>14 follicles>=11mm) and hence at risk for developing ovarian hyperstimulation syndrome (OHSS), treated with a GnRH antagonist protocol and are administered GnRH agonist to trigger final oocyte maturation. All resulting embryos (blastocysts) will be cryopreserved and transferred in a subsequent frozen cycle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Follicle development in women undergoing IVF will be monitored either by conventional 2D ultrasound or SonoAVC.
| Arm | Type | Receives |
|---|---|---|
| 2D ultrasound | Active comparator | Device: 2D ultrasoundTwo-dimensional (2D) ultrasound is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation. |
| SonoAVC | Active comparator | Device: SonoAVCSonoAVC is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- AMH >= 3ng/ml
- at least 14 follicles =>11 mm diameter on final day of stimulation
- undergoing GnRH antagonist protocol
- administered GnRH agonist to trigger final oocyte maturation
Key exclusion criteria (2 listed)
- poor responders
- hCG injection to trigger final oocyte maturation
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 |
|---|---|---|
| 2D ultrasoundThe timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of conventional two-dimensional (2D) ultrasound. | Device | 2D ultrasound |
| SonoAVCThe timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of SonoAVC. | Device | SonoAVC |
Primary outcome
Number of mature oocytes
Time frame: Day of oocyte retrieval
The number of mature (metaphase-II) oocytes retrieved
8 secondary outcomes
Number of oocytes retrieved
Time frame: Day of oocyte retrieval
Oocyte maturation rate
Time frame: Day of oocyte retrieval
Oocyte retrieval rate
Time frame: Day of oocyte retrieval
Number of fertilised oocytes
Time frame: 1 day post oocyte retrieval
Fertilisation rate
Time frame: 1 day post oocyte retrieval
Number of blastocysts
Time frame: 5 days post oocyte retrieval
Days of stimulation
Time frame: 10-15 days after menses
Total dose of recFSH
Time frame: 10-15 days after menses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Background: PubMed 19342014Raine-Fenning N, Deb S, Jayaprakasan K, Clewes J, Hopkisson J, Campbell B. Timing of oocyte maturation and egg collection during controlled ovarian stimulation: a randomized controlled trial evaluating manual and automated measurements of follicle diameter. Fertil Steril. 2010 Jun;94(1):184-8. doi: 10.1016/j.fertnstert.2009.02.063. Epub 2009 Apr 1.
- Background: PubMed 20226448Lamazou F, Arbo E, Salama S, Grynberg M, Frydman R, Fanchin R. Reliability of automated volumetric measurement of multiple growing follicles in controlled ovarian hyperstimulation. Fertil Steril. 2010 Nov;94(6):2172-6. doi: 10.1016/j.fertnstert.2010.01.062. Epub 2010 Mar 12.
- Background: PubMed 19342038Salama S, Arbo E, Lamazou F, Levailllant JM, Frydman R, Fanchin R. Reproducibility and reliability of automated volumetric measurement of single preovulatory follicles using SonoAVC. Fertil Steril. 2010 Apr;93(6):2069-73. doi: 10.1016/j.fertnstert.2008.12.115. Epub 2009 Apr 1.
- Background: PubMed 21112951Ata B, Seyhan A, Reinblatt SL, Shalom-Paz E, Krishnamurthy S, Tan SL. Comparison of automated and manual follicle monitoring in an unrestricted population of 100 women undergoing controlled ovarian stimulation for IVF. Hum Reprod. 2011 Jan;26(1):127-33. doi: 10.1093/humrep/deq320. Epub 2010 Nov 26.
- Background: PubMed 19376513Rodriguez-Fuentes A, Hernandez J, Garcia-Guzman R, Chinea E, Iaconianni L, Palumbo A. Prospective evaluation of automated follicle monitoring in 58 in vitro fertilization cycles: follicular volume as a new indicator of oocyte maturity. Fertil Steril. 2010 Feb;93(2):616-20. doi: 10.1016/j.fertnstert.2009.02.058. Epub 2009 Apr 18.
- Background: PubMed 25420733Revelli A, Martiny G, Delle Piane L, Benedetto C, Rinaudo P, Tur-Kaspa I. A critical review of bi-dimensional and three-dimensional ultrasound techniques to monitor follicle growth: do they help improving IVF outcome? Reprod Biol Endocrinol. 2014 Nov 24;12:107. doi: 10.1186/1477-7827-12-107.
- Background: PubMed 20069654Deb S, Campbell BK, Clewes JS, Raine-Fenning NJ. Quantitative analysis of antral follicle number and size: a comparison of two-dimensional and automated three-dimensional ultrasound techniques. Ultrasound Obstet Gynecol. 2010 Mar;35(3):354-60. doi: 10.1002/uog.7505.
- Background: PubMed 18937942Deutch TD, Joergner I, Matson DO, Oehninger S, Bocca S, Hoenigmann D, Abuhamad A. Automated assessment of ovarian follicles using a novel three-dimensional ultrasound software. Fertil Steril. 2009 Nov;92(5):1562-8. doi: 10.1016/j.fertnstert.2008.08.102. Epub 2008 Oct 19.
- Background: PubMed 25593942Vandekerckhove F, Bracke V, De Sutter P. The Value of Automated Follicle Volume Measurements in IVF/ICSI. Front Surg. 2014 May 28;1:18. doi: 10.3389/fsurg.2014.00018. eCollection 2014.
- Background: PubMed 24130840Pan P, Chen X, Li Y, Zhang Q, Zhao X, Bodombossou-Djobo MM, Yang D. Comparison of manual and automated measurements of monodominant follicle diameter with different follicle size in infertile patients. PLoS One. 2013 Oct 10;8(10):e77095. doi: 10.1371/journal.pone.0077095. eCollection 2013.
- Background: PubMed 18930205Raine-Fenning N, Jayaprakasan K, Chamberlain S, Devlin L, Priddle H, Johnson I. Automated measurements of follicle diameter: a chance to standardize? Fertil Steril. 2009 Apr;91(4 Suppl):1469-72. doi: 10.1016/j.fertnstert.2008.07.1719. Epub 2008 Oct 18.
- Background: PubMed 18484679Raine-Fenning N, Jayaprakasan K, Clewes J, Joergner I, Bonaki SD, Chamberlain S, Devlin L, Priddle H, Johnson I. SonoAVC: a novel method of automatic volume calculation. Ultrasound Obstet Gynecol. 2008 Jun;31(6):691-6. doi: 10.1002/uog.5359.
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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.
Tryfon Lainas, PhD study director
Eugonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D ultrasound and SonoAVC in people with Infertility, run by Eugonia at 1 site in Greece.
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 4 inclusion and 2 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 8 Feb 2019. 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 Greece. 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?
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?
Number of mature oocytes (time frame: Day of oocyte retrieval). 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 NCT03610009, which also lists 14 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 8 Feb 2019.