Embryo ImplantationNCT04721522
The Impact of Endometrial Compaction on Assisted Reproductive Technology Outcome
An observational study of Embryo Implantation and ART, run by Zagazig University at 1 site in Egypt.
Trial summary
Absence of endometrial compaction on the day of ET has adverse effects on success of ART outcome. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Embryo Implantation, ART
- What is being tested?
- blood sampling & ultrasound
- How many people
- 356 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2021to 1 Jun 2024
- Phase
- Observational
- 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 37 years
- Women only
- Adult
Study population: It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.
Who may be able to join
- All women should have the following:
- Aged from 18 - 37 years old. Undergoing fresh ICSI cycles. A normal uterus with no anomalies or pathologies. At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
- Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).
Who cannot join
- Younger than 18 or older than 37 years old. Congenital uterine abnormality or pathology. Presence of a hydrosalpinx. Chronic diseases which are not suitable for pregnancy. ICSI cycles with fresh or frozen TESE samples.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig university
Zagazig, 44511
rana nabil, msc, 01005899460, rananabil51@gmail.com
Eman ElGindy, MD, PhD, 01227491143, eman_elgindy2013@hotmail.com
About this study
Absence of endometrial compaction on the day of ET has adverse effects on success of ART outcome.
Read the detailed description
Implantation is a complex process which requires coordination and interaction between a blastocyst and the endometrium. Impaired embryo quality or impaired endometrial receptivity may negatively affect this interaction that in turn results in implantation failure (Diedrich et al., 2007). . Successful implantation entails a process of strict synchronization of endometrial and blastocyst development. (Maged et al., 2018).
Despite advancements made since the introduction of assisted reproductive technology (ART), fewer than 40% of ART treatment cycles result in a live birth. Endometrial receptivity remains a crucial rate-limiting step affecting the success of ART treatment. Embryos are thought to be responsible for one-third of implantation failures, whereas the remaining two-thirds result from sub-optimal endometrial receptivity or abnormal embryo-endometrium dialogue.(Craciunas et al., 2019).
There are 3 main methods used to assess endometrial receptivity: endometrial biopsy, hormone profile, and ultrasound imaging.(Lawrenz and Fatemi, 2017). Ultrasound has been established as an appreciated, simple, and non-invasive technique in evaluation of endometrial preparation before embryo transfer in IVF cycles. Several sonographic parameters have been assessed that include endometrial thickness (Ent), endometrial pattern (EnP) and sub-endometrial blood flow.(Kader et al., 2016).
Endometrial thickness (EMT) is the most used prognostic factor for endometrial receptivity during ART (Kasius et al., 2014). Both clinical pregnancy and live birth rates decreased significantly for each millimeter below 8 mm in fresh IVF-ET cycles and below 7 mm frozen ET cycles (Liu et al 2018). Regarding endometrial patterns (Yuan et al., 2016) and vascularization (Ng et al., 2007) data are still contradictory. Increased frequency of contractility prior to embryo transfer was inversely related to clinical pregnancy in fresh and frozen embryo transfer cycles. (Zhu et al., 2014).
Currently, there is an emphasis on a new endometrial parameter called endometrial compaction, which is the decrease in endometrial thickness on the day of ET. In a Study of 274 frozen embryo transfer cycles, patients whose endometrium compacted had a significantly higher ongoing pregnancy rate than patients whose endometrium became thicker or did not change.(Haas et al., 2019).
On the other hand, a large-scale cohort study revealed that an increased endometrium thickness after progesterone administration in FET was associated with better pregnancy outcome.(Bu et al., 2019). The role of endometrial compaction in fresh ART cycles is not yet studied. So, it's better to test its effect on fresh cycles ART outcome.
- Conditions
- Embryo Implantation, ART
- Being tested
- blood sampling & ultrasound
- Keywords
- Endometrial Compaction, endometrial receptivity, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling & ultrasoundDiagnostic test
Blood sampling:
Serum P4 \& estradiol will be performed on the day of triggering and on the day of embryo transfer. Progesterone/ Estradiol (P4/E2) ratio will be calculated Ultrasound: On triggering day, at time of ovum pick up and on ET day, we will measure
- Endometrial thickness
- Endometrial pattern
- Endometrial compaction: the difference in measurement of endometrial thickness between the day of embryo transfer and the day of triggering.
- Junctional zone thickness
- Uterine contraction (peristalsis).
- Blood flow of uterine vessels: PI of the uterine arteries will be calculated also Endometrial - sub endometrial blood flow
| Study group | Role | What they receive |
|---|---|---|
| 356 case will be enrolled | Pituitary suppression will be achieved by long or antagonist protocol. For long protocol, GnRH agonist will be administered for 10-14 days starting from mid-luteal phase of preceding cycle. After confirmation of down regulation, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). Gonadotropins therapy will be tailored according to age, BMI, antral follicle count, antimullerian hormone and previous response. In antagonist protocol, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). GnRH antagonist will be adjusted according to patient response. On the 5th -6th day of stimulation, sonography will be performed and repeated every 1-3 days with regular estradiol assessment. When at least 3 follicles reach ≥ 17 mm in mean diameter, trigger will be given. Oocytes pick up will be performed 34-36 hour after triggering. Receives: Diagnostic Test: blood sampling & ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether the occurrence of endometrial compaction on the day of embryo transfer has a role in optimizing ongoing pregnancy rate in ART cycles
Percent of endometrial compaction will be calculated as the difference in measurement of endometrial thickness between the day of embryo transfer and the day of triggering.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start29 Jan 2021
- Primary completion20 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Embryo ImplantationStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rana Nabil Mohamed Attia, Zagazig University
- Investigators
- rana nabil, Msc, Principal investigator, zagazig university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721522
- Sponsor's protocol ID
- 6549
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diedrich K, Fauser BC, Devroey P, Griesinger G; Evian Annual Reproduction (EVAR) Workshop Group. The role of the endometrium and embryo in human implantation. Hum Reprod Update. 2007 Jul-Aug;13(4):365-77. doi: 10.1093/humupd/dmm011. Epub 2007 Jun 4.
PubMed 17548368Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.
PubMed 29048754Craciunas L, Gallos I, Chu J, Bourne T, Quenby S, Brosens JJ, Coomarasamy A. Conventional and modern markers of endometrial receptivity: a systematic review and meta-analysis. Hum Reprod Update. 2019 Mar 1;25(2):202-223. doi: 10.1093/humupd/dmy044.
PubMed 30624659Lawrenz B, Fatemi HM. Effect of progesterone elevation in follicular phase of IVF-cycles on the endometrial receptivity. Reprod Biomed Online. 2017 Apr;34(4):422-428. doi: 10.1016/j.rbmo.2017.01.011. Epub 2017 Jan 24.
PubMed 28162937Kader MA, Abdelmeged A, Mahran A, Samra MFA, Bahaa H (2016) The usefulness of endometrial thickness, morphology, and vasculature by 2D Doppler ultrasound in prediction of pregnancy in IVF/ICSI cycles. Egypt J Radiol Ncl Med 47(1):341-346.
Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
PubMed 24664156Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
PubMed 30239738Yuan X, Saravelos SH, Wang Q, Xu Y, Li TC, Zhou C. Endometrial thickness as a predictor of pregnancy outcomes in 10787 fresh IVF-ICSI cycles. Reprod Biomed Online. 2016 Aug;33(2):197-205. doi: 10.1016/j.rbmo.2016.05.002. Epub 2016 May 13.
PubMed 27238372Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Endometrial and subendometrial vascularity is higher in pregnant patients with livebirth following ART than in those who suffer a miscarriage. Hum Reprod. 2007 Apr;22(4):1134-41. doi: 10.1093/humrep/del458. Epub 2006 Dec 5.
PubMed 17148577Zhu L, Che HS, Xiao L, Li YP. Uterine peristalsis before embryo transfer affects the chance of clinical pregnancy in fresh and frozen-thawed embryo transfer cycles. Hum Reprod. 2014 Jun;29(6):1238-43. doi: 10.1093/humrep/deu058. Epub 2014 Mar 23.
PubMed 24664129Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
PubMed 31248618Bu Z, Yang X, Song L, Kang B, Sun Y. The impact of endometrial thickness change after progesterone administration on pregnancy outcome in patients transferred with single frozen-thawed blastocyst. Reprod Biol Endocrinol. 2019 Nov 25;17(1):99. doi: 10.1186/s12958-019-0545-0.
PubMed 31767010
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Endometrial Compaction on Assisted Reproductive Technology Outcome
- ClinicalTrials.gov ID
- NCT04721522
- Acronym / sponsor ID
- 6549
- Conditions
- Embryo Implantation, ART
- Keywords
- Endometrial Compaction, endometrial receptivity, ART
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Jan 2021 (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.
Absence of endometrial compaction on the day of ET has adverse effects on success of ART outcome.
Detailed description
Implantation is a complex process which requires coordination and interaction between a blastocyst and the endometrium. Impaired embryo quality or impaired endometrial receptivity may negatively affect this interaction that in turn results in implantation failure (Diedrich et al., 2007). . Successful implantation entails a process of strict synchronization of endometrial and blastocyst development. (Maged et al., 2018).
Despite advancements made since the introduction of assisted reproductive technology (ART), fewer than 40% of ART treatment cycles result in a live birth. Endometrial receptivity remains a crucial rate-limiting step affecting the success of ART treatment. Embryos are thought to be responsible for one-third of implantation failures, whereas the remaining two-thirds result from sub-optimal endometrial receptivity or abnormal embryo-endometrium dialogue.(Craciunas et al., 2019).
There are 3 main methods used to assess endometrial receptivity: endometrial biopsy, hormone profile, and ultrasound imaging.(Lawrenz and Fatemi, 2017). Ultrasound has been established as an appreciated, simple, and non-invasive technique in evaluation of endometrial preparation before embryo transfer in IVF cycles. Several sonographic parameters have been assessed that include endometrial thickness (Ent), endometrial pattern (EnP) and sub-endometrial blood flow.(Kader et al., 2016).
Endometrial thickness (EMT) is the most used prognostic factor for endometrial receptivity during ART (Kasius et al., 2014). Both clinical pregnancy and live birth rates decreased significantly for each millimeter below 8 mm in fresh IVF-ET cycles and below 7 mm frozen ET cycles (Liu et al 2018). Regarding endometrial patterns (Yuan et al., 2016) and vascularization (Ng et al., 2007) data are still contradictory. Increased frequency of contractility prior to embryo transfer was inversely related to clinical pregnancy in fresh and frozen embryo transfer cycles. (Zhu et al., 2014).
Currently, there is an emphasis on a new endometrial parameter called endometrial compaction, which is the decrease in endometrial thickness on the day of ET. In a Study of 274 frozen embryo transfer cycles, patients whose endometrium compacted had a significantly higher ongoing pregnancy rate than patients whose endometrium became thicker or did not change.(Haas et al., 2019).
On the other hand, a large-scale cohort study revealed that an increased endometrium thickness after progesterone administration in FET was associated with better pregnancy outcome.(Bu et al., 2019). The role of endometrial compaction in fresh ART cycles is not yet studied. So, it's better to test its effect on fresh cycles ART outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 356 case will be enrolled | – | Diagnostic Test: blood sampling & ultrasoundPituitary suppression will be achieved by long or antagonist protocol. For long protocol, GnRH agonist will be administered for 10-14 days starting from mid-luteal phase of preceding cycle. After confirmation of down regulation, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). Gonadotropins therapy will be tailored according to age, BMI, antral follicle count, antimullerian hormone and previous response. In antagonist protocol, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). GnRH antagonist will be adjusted according to patient response. On the 5th -6th day of stimulation, sonography will be performed and repeated every 1-3 days with regular estradiol assessment. When at least 3 follicles reach ≥ 17 mm in mean diameter, trigger will be given. Oocytes pick up will be performed 34-36 hour after triggering. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.
Key inclusion criteria (3 listed)
- All women should have the following:
- Aged from 18 - 37 years old. Undergoing fresh ICSI cycles. A normal uterus with no anomalies or pathologies. At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
- Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).
Key exclusion criteria (1 listed)
- Younger than 18 or older than 37 years old. Congenital uterine abnormality or pathology. Presence of a hydrosalpinx. Chronic diseases which are not suitable for pregnancy. ICSI cycles with fresh or frozen TESE samples.
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 |
|---|---|---|
| blood sampling & ultrasoundBlood sampling: Serum P4 \& estradiol will be performed on the day of triggering and on the day of embryo transfer. Progesterone/ Estradiol (P4/E2) ratio will be calculated Ultrasound: On triggering day, at time of ovum pick up and on ET day, we will measure 1. Endometrial thickness 2. Endometrial pattern 3. Endometrial compaction: the difference in measurement of endometrial thickness between the day of embryo transfer and the day of triggering. 4. Junctional zone thickness 5. Uterine contraction (peristalsis). 6. Blood flow of uterine vessels: PI of the uterine arteries will be calculated also Endometrial - sub endometrial blood flow | Diagnostic test | 356 case will be enrolled |
Primary outcome
whether the occurrence of endometrial compaction on the day of embryo transfer has a role in optimizing ongoing pregnancy rate in ART cycles
Time frame: 2 weeks
Percent of endometrial compaction will be calculated as the difference in measurement of endometrial thickness between the day of embryo transfer and the day of triggering.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 17548368Diedrich K, Fauser BC, Devroey P, Griesinger G; Evian Annual Reproduction (EVAR) Workshop Group. The role of the endometrium and embryo in human implantation. Hum Reprod Update. 2007 Jul-Aug;13(4):365-77. doi: 10.1093/humupd/dmm011. Epub 2007 Jun 4.
- Background: PubMed 29048754Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.
- Background: PubMed 30624659Craciunas L, Gallos I, Chu J, Bourne T, Quenby S, Brosens JJ, Coomarasamy A. Conventional and modern markers of endometrial receptivity: a systematic review and meta-analysis. Hum Reprod Update. 2019 Mar 1;25(2):202-223. doi: 10.1093/humupd/dmy044.
- Background: PubMed 28162937Lawrenz B, Fatemi HM. Effect of progesterone elevation in follicular phase of IVF-cycles on the endometrial receptivity. Reprod Biomed Online. 2017 Apr;34(4):422-428. doi: 10.1016/j.rbmo.2017.01.011. Epub 2017 Jan 24.
- BackgroundKader MA, Abdelmeged A, Mahran A, Samra MFA, Bahaa H (2016) The usefulness of endometrial thickness, morphology, and vasculature by 2D Doppler ultrasound in prediction of pregnancy in IVF/ICSI cycles. Egypt J Radiol Ncl Med 47(1):341-346.
- Background: PubMed 24664156Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
- Background: PubMed 30239738Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
- Background: PubMed 27238372Yuan X, Saravelos SH, Wang Q, Xu Y, Li TC, Zhou C. Endometrial thickness as a predictor of pregnancy outcomes in 10787 fresh IVF-ICSI cycles. Reprod Biomed Online. 2016 Aug;33(2):197-205. doi: 10.1016/j.rbmo.2016.05.002. Epub 2016 May 13.
- Background: PubMed 17148577Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Endometrial and subendometrial vascularity is higher in pregnant patients with livebirth following ART than in those who suffer a miscarriage. Hum Reprod. 2007 Apr;22(4):1134-41. doi: 10.1093/humrep/del458. Epub 2006 Dec 5.
- Background: PubMed 24664129Zhu L, Che HS, Xiao L, Li YP. Uterine peristalsis before embryo transfer affects the chance of clinical pregnancy in fresh and frozen-thawed embryo transfer cycles. Hum Reprod. 2014 Jun;29(6):1238-43. doi: 10.1093/humrep/deu058. Epub 2014 Mar 23.
- Background: PubMed 31248618Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
- Background: PubMed 31767010Bu Z, Yang X, Song L, Kang B, Sun Y. The impact of endometrial thickness change after progesterone administration on pregnancy outcome in patients transferred with single frozen-thawed blastocyst. Reprod Biol Endocrinol. 2019 Nov 25;17(1):99. doi: 10.1186/s12958-019-0545-0.
- Individual participant dataSharing planned: Undecided
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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.
rana nabil, Msc principal investigator
zagazig university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Implantation and ART, run by Zagazig University at 1 site in Egypt.
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 1 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 10 Apr 2024. 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 Egypt. 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?
Contact eman ElGindy, MD, PhD (01227491143, eman_elgindy2013@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether the occurrence of endometrial compaction on the day of embryo transfer has a role in optimizing ongoing pregnancy rate in ART cycles (time frame: 2 weeks). 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 NCT04721522, which also lists 12 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 10 Apr 2024.