Fertility IssuesNCT04748172
COVID-19 Vaccine and Ovarian Reserve
An observational study of Fertility Issues and Vaccine Adverse Reaction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
As Israel is the first country to widely vaccinate its population using the mRNA vaccine against COVID-19, evaluating its influence on ovarian reserve is essential . Read more about this study
- Who is it for?
- Ages 11 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues, Vaccine Adverse Reaction
- What is being tested?
- SARS-CoV-2 virus vaccines, AMH sampling and anti Covid-19 antibody levels (Serology)
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2021to 1 Jun 2023
- 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 11 to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Females (age 11 to 42) that are planning to be vaccinated in Israel
Who may be able to join
- Age 11-42
- No previous exposure to Covid-19 vaccine (first or second dose)
- No known past Covid-19 infection
Who cannot join
- Premature ovarian failure
- Pregnancy
- Fertility treatment
- Past Covid-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of COVID -19 mRNA Vaccine on Ovarian Reserve
As Israel is the first country to widely vaccinate its population using the mRNA vaccine against COVID-19, evaluating its influence on ovarian reserve is essential .
Read the detailed description
Introduction:
Although there is as yet no scientific evidence that a SARS-CoV-2 virus infection could have negative effects on fertility, currently the possibility that the virus could affect sperm function and egg performance cannot be excluded. Previous studies have already shown an association between influenza and infertility. SARS-CoV-2 seems to be far more aggressive in terms of severe illness, morbidity and mortality in comparison to common influenzas, thus it is reasonable to hypothesize a possible substantial effect of Covid-19 on fertility.
At the cellular level, common influenza viruses promote oxidant-sensitive pathways, leading to increased oxidative stress. This mechanism has been blamed to cause male infertility through a reduction of progressive motility in spermatozoa and a simultaneous increase in sperm DNA fragmentation. Based on this pathogenic pathway, it can be hypothesized that SARS-CoV-2 could increase sperm DNA fragmentation, which might affect fertilizing potential. Along the same lines, SARS-CoV-2 may affect oocyte performance through mechanisms that increase oxidative stress.
As SARS-CoV-2 acts through the angiotensin-converting enzyme 2 (ACE2) receptor, this was proposed as an additional pathway affecting ovaria follicles and oocytes. ACE2 receptors are expressed in human ovaries, while angiotensin has been detected in measurable amounts in the follicular fluid . Therefore, a possible negative impact of the virus through an interaction between the oocyte and the somatic cells cannot be ruled out.
The COVID-19 pandemic exerted tremendous pressure on scientists to develop safe and effective vaccines. A few delivery systems for next-generation vaccines against COVID-19 were introduced. The new-generation vaccines include only a specific antigen or antigens of the pathogen, instead of the whole pathogen, thus providing a better safety profile. While SARS-CoV-2 has four main structural proteins, the spike protein (S) which is located at the outer surface of the virus particles and can bind to ACE2 on the cell surface and causes receptor-mediated endocytosis of the virus, is the main target to evoke the self-immune system.
The mRNA vaccines represent the newest generation of vaccines in which all components can be engineered via chemical synthesis. Due to the mRNA molecules' low apparent transfection efficacy, lipid nanoparticles (LNPs) are often used to incorporate the mRNA molecules for transfection purposes. An additional advantage of the mRNA vaccine is that the antigen expression generated by the mRNA is a transient process and therefore the risk of host DNA integration is negligible. Furthermore, elimination of live materials poses an advantage from a quality control standpoint and allows quick product switching in manufacturing facilities. Since the process is fully-synthetic it also eliminates the risk of disease transmissions from the manufacturing facility. The effect of the systemic generation and introduction of just the S protein of the SARS-CoV-2 could have a negative influence on ovarian follicles and oocytes has not been studied yet.
Anti Mullarian Hormone (AMH) is a glycoprotein produced by the granulosa cells of the antral follicles. Its circulating levels are associated with the fertility state of the ovary and in contrast to other hormones are not influenced by the state of the menstrual cycle. Therefore, AMH levels are considered the measurement of choice for estimating ovarian reserve.
As Israel is the first country to widely vaccinate its population using the mRNA vaccines and due to all the aforementioned, the aim of this study is to evaluate the influence of the mRNA vaccines on ovarian reserve estimated by the change in AMH before and three-month following vaccination.
Material and Methods:
This is a prospective study including females that are planning to be vaccinated in Israel. Women will be asked to sign an informed consent to participate in the study while visiting the ambulatory vaccinating clinics before being vaccinated. Medical information will be collected by the research team during this visit using computerized questionnaire. Blood samples will be collected for AMH analysis before administration of the first mRNA vaccine shot. A follow up visit will be scheduled at three months after the first vaccination. During this visit, blood samples will be collected for AMH levels and for anti Covid-19 antibody levels (Serology). Additionally, women will be asked to complete a second computerized questionnaire which focused on possible adverse effects following vaccinations and gynecological well-being at 3,6 and 12 months from recruitment.
- Conditions
- Fertility Issues, Vaccine Adverse Reaction
- Being tested
- SARS-CoV-2 virus vaccines, AMH sampling, anti Covid-19 antibody levels (Serology)
- Keywords
- Ovarian reserve, Corona-19 virus, SARS-CoV-2
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 virus vaccinesBiological
mRNA SARS-CoV-2 virus vaccines ( By Pfizer or Moderna)
AMH samplingDiagnostic test
Blood sample for AMH on recruitment and after three months
anti Covid-19 antibody levels (Serology)Diagnostic test
Blood sample for IgG against S1 protein after three months
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Women who are planning to be vaccinated | Women that are planning to be vaccinated, before receiving the first shot of the vaccine Receives: Biological: SARS-CoV-2 virus vaccines; Diagnostic Test: AMH sampling; Diagnostic Test: anti Covid-19 antibody levels (Serology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta in AMH levels
AMA levels on recruitment minos AMH levels after three months
Measured: From first vaccination until the second AMH sampling - after three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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 Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748172
- Sponsor's protocol ID
- 8121-21-SMC
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request
Publications
Anifandis G, Messini CI, Daponte A, Messinis IE. COVID-19 and fertility: a virtual reality. Reprod Biomed Online. 2020 Aug;41(2):157-159. doi: 10.1016/j.rbmo.2020.05.001. Epub 2020 May 8.
PubMed 32466995Joguet G, Mansuy JM, Matusali G, Hamdi S, Walschaerts M, Pavili L, Guyomard S, Prisant N, Lamarre P, Dejucq-Rainsford N, Pasquier C, Bujan L. Effect of acute Zika virus infection on sperm and virus clearance in body fluids: a prospective observational study. Lancet Infect Dis. 2017 Nov;17(11):1200-1208. doi: 10.1016/S1473-3099(17)30444-9. Epub 2017 Aug 23.
PubMed 28838639Percivalle E, Zavattoni M, Fausto F, Rovida F. Zika virus isolation from semen. New Microbiol. 2017 Jul;40(3):197-198. Epub 2017 May 17.
PubMed 28513814Khomich OA, Kochetkov SN, Bartosch B, Ivanov AV. Redox Biology of Respiratory Viral Infections. Viruses. 2018 Jul 26;10(8):392. doi: 10.3390/v10080392.
PubMed 30049972Liu M, Chen F, Liu T, Chen F, Liu S, Yang J. The role of oxidative stress in influenza virus infection. Microbes Infect. 2017 Dec;19(12):580-586. doi: 10.1016/j.micinf.2017.08.008. Epub 2017 Sep 14.
PubMed 28918004Agarwal A, Rana M, Qiu E, AlBunni H, Bui AD, Henkel R. Role of oxidative stress, infection and inflammation in male infertility. Andrologia. 2018 Dec;50(11):e13126. doi: 10.1111/and.13126.
PubMed 30569652Dutta S, Majzoub A, Agarwal A. Oxidative stress and sperm function: A systematic review on evaluation and management. Arab J Urol. 2019 Apr 24;17(2):87-97. doi: 10.1080/2090598X.2019.1599624. eCollection 2019.
PubMed 31285919Homa ST, Vassiliou AM, Stone J, Killeen AP, Dawkins A, Xie J, Gould F, Ramsay JWA. A Comparison Between Two Assays for Measuring Seminal Oxidative Stress and their Relationship with Sperm DNA Fragmentation and Semen Parameters. Genes (Basel). 2019 Mar 19;10(3):236. doi: 10.3390/genes10030236.
PubMed 30893955Kuhn JH, Li W, Choe H, Farzan M. Angiotensin-converting enzyme 2: a functional receptor for SARS coronavirus. Cell Mol Life Sci. 2004 Nov;61(21):2738-43. doi: 10.1007/s00018-004-4242-5.
PubMed 15549175Reis FM, Bouissou DR, Pereira VM, Camargos AF, dos Reis AM, Santos RA. Angiotensin-(1-7), its receptor Mas, and the angiotensin-converting enzyme type 2 are expressed in the human ovary. Fertil Steril. 2011 Jan;95(1):176-81. doi: 10.1016/j.fertnstert.2010.06.060. Epub 2010 Aug 1.
PubMed 20674894Wang J, Peng Y, Xu H, Cui Z, Williams RO 3rd. The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation. AAPS PharmSciTech. 2020 Aug 5;21(6):225. doi: 10.1208/s12249-020-01744-7.
PubMed 32761294Vartak A, Sucheck SJ. Recent Advances in Subunit Vaccine Carriers. Vaccines (Basel). 2016 Apr 19;4(2):12. doi: 10.3390/vaccines4020012.
PubMed 27104575Mohr-Sasson A, Haas J, Sivan M, Zehori Y, Hemi R, Orvieto R, Afek A, Rabinovici J. The effects of Covid-19 mRNA vaccine on adolescence gynecological well-being. Arch Gynecol Obstet. 2023 May;307(5):1625-1631. doi: 10.1007/s00404-023-06981-2. Epub 2023 Mar 5.
PubMed 36871101Mohr-Sasson A, Haas J, Abuhasira S, Sivan M, Doitch Amdurski H, Dadon T, Blumenfeld S, Derazne E, Hemi R, Orvieto R, Afek A, Rabinovici J. The effect of Covid-19 mRNA vaccine on serum anti-Mullerian hormone levels. Hum Reprod. 2022 Mar 1;37(3):534-541. doi: 10.1093/humrep/deab282.
PubMed 34935913
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of COVID -19 mRNA Vaccine on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT04748172
- Acronym / sponsor ID
- 8121-21-SMC
- Conditions
- Fertility Issues, Vaccine Adverse Reaction
- Keywords
- Ovarian reserve, Corona-19 virus, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Feb 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.
As Israel is the first country to widely vaccinate its population using the mRNA vaccine against COVID-19, evaluating its influence on ovarian reserve is essential .
Detailed description
Introduction:
Although there is as yet no scientific evidence that a SARS-CoV-2 virus infection could have negative effects on fertility, currently the possibility that the virus could affect sperm function and egg performance cannot be excluded. Previous studies have already shown an association between influenza and infertility. SARS-CoV-2 seems to be far more aggressive in terms of severe illness, morbidity and mortality in comparison to common influenzas, thus it is reasonable to hypothesize a possible substantial effect of Covid-19 on fertility.
At the cellular level, common influenza viruses promote oxidant-sensitive pathways, leading to increased oxidative stress. This mechanism has been blamed to cause male infertility through a reduction of progressive motility in spermatozoa and a simultaneous increase in sperm DNA fragmentation. Based on this pathogenic pathway, it can be hypothesized that SARS-CoV-2 could increase sperm DNA fragmentation, which might affect fertilizing potential. Along the same lines, SARS-CoV-2 may affect oocyte performance through mechanisms that increase oxidative stress.
As SARS-CoV-2 acts through the angiotensin-converting enzyme 2 (ACE2) receptor, this was proposed as an additional pathway affecting ovaria follicles and oocytes. ACE2 receptors are expressed in human ovaries, while angiotensin has been detected in measurable amounts in the follicular fluid . Therefore, a possible negative impact of the virus through an interaction between the oocyte and the somatic cells cannot be ruled out.
The COVID-19 pandemic exerted tremendous pressure on scientists to develop safe and effective vaccines. A few delivery systems for next-generation vaccines against COVID-19 were introduced. The new-generation vaccines include only a specific antigen or antigens of the pathogen, instead of the whole pathogen, thus providing a better safety profile. While SARS-CoV-2 has four main structural proteins, the spike protein (S) which is located at the outer surface of the virus particles and can bind to ACE2 on the cell surface and causes receptor-mediated endocytosis of the virus, is the main target to evoke the self-immune system.
The mRNA vaccines represent the newest generation of vaccines in which all components can be engineered via chemical synthesis. Due to the mRNA molecules' low apparent transfection efficacy, lipid nanoparticles (LNPs) are often used to incorporate the mRNA molecules for transfection purposes. An additional advantage of the mRNA vaccine is that the antigen expression generated by the mRNA is a transient process and therefore the risk of host DNA integration is negligible. Furthermore, elimination of live materials poses an advantage from a quality control standpoint and allows quick product switching in manufacturing facilities. Since the process is fully-synthetic it also eliminates the risk of disease transmissions from the manufacturing facility. The effect of the systemic generation and introduction of just the S protein of the SARS-CoV-2 could have a negative influence on ovarian follicles and oocytes has not been studied yet.
Anti Mullarian Hormone (AMH) is a glycoprotein produced by the granulosa cells of the antral follicles. Its circulating levels are associated with the fertility state of the ovary and in contrast to other hormones are not influenced by the state of the menstrual cycle. Therefore, AMH levels are considered the measurement of choice for estimating ovarian reserve.
As Israel is the first country to widely vaccinate its population using the mRNA vaccines and due to all the aforementioned, the aim of this study is to evaluate the influence of the mRNA vaccines on ovarian reserve estimated by the change in AMH before and three-month following vaccination.
Material and Methods:
This is a prospective study including females that are planning to be vaccinated in Israel. Women will be asked to sign an informed consent to participate in the study while visiting the ambulatory vaccinating clinics before being vaccinated. Medical information will be collected by the research team during this visit using computerized questionnaire. Blood samples will be collected for AMH analysis before administration of the first mRNA vaccine shot. A follow up visit will be scheduled at three months after the first vaccination. During this visit, blood samples will be collected for AMH levels and for anti Covid-19 antibody levels (Serology). Additionally, women will be asked to complete a second computerized questionnaire which focused on possible adverse effects following vaccinations and gynecological well-being at 3,6 and 12 months from recruitment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group: Women who are planning to be vaccinated | – | Biological: SARS-CoV-2 virus vaccines, Diagnostic Test: AMH sampling, Diagnostic Test: anti Covid-19 antibody levels (Serology)Women that are planning to be vaccinated, before receiving the first shot of the vaccine |
Who may qualify
- Ages
- 11 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Females (age 11 to 42) that are planning to be vaccinated in Israel
Key inclusion criteria (3 listed)
- Age 11-42
- No previous exposure to Covid-19 vaccine (first or second dose)
- No known past Covid-19 infection
Key exclusion criteria (4 listed)
- Premature ovarian failure
- Pregnancy
- Fertility treatment
- Past Covid-19 infection
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 |
|---|---|---|
| SARS-CoV-2 virus vaccinesmRNA SARS-CoV-2 virus vaccines ( By Pfizer or Moderna) | Biological | Study Group: Women who are planning to be vaccinated |
| AMH samplingBlood sample for AMH on recruitment and after three months | Diagnostic test | Study Group: Women who are planning to be vaccinated |
| anti Covid-19 antibody levels (Serology)Blood sample for IgG against S1 protein after three months | Diagnostic test | Study Group: Women who are planning to be vaccinated |
Primary outcome
Delta in AMH levels
Time frame: From first vaccination until the second AMH sampling - after three month
AMA levels on recruitment minos AMH levels after three months
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 22 Jun 2023.
- Results publication: PubMed 32466995Anifandis G, Messini CI, Daponte A, Messinis IE. COVID-19 and fertility: a virtual reality. Reprod Biomed Online. 2020 Aug;41(2):157-159. doi: 10.1016/j.rbmo.2020.05.001. Epub 2020 May 8.
- Results publication: PubMed 28838639Joguet G, Mansuy JM, Matusali G, Hamdi S, Walschaerts M, Pavili L, Guyomard S, Prisant N, Lamarre P, Dejucq-Rainsford N, Pasquier C, Bujan L. Effect of acute Zika virus infection on sperm and virus clearance in body fluids: a prospective observational study. Lancet Infect Dis. 2017 Nov;17(11):1200-1208. doi: 10.1016/S1473-3099(17)30444-9. Epub 2017 Aug 23.
- Results publication: PubMed 28513814Percivalle E, Zavattoni M, Fausto F, Rovida F. Zika virus isolation from semen. New Microbiol. 2017 Jul;40(3):197-198. Epub 2017 May 17.
- Results publication: PubMed 30049972Khomich OA, Kochetkov SN, Bartosch B, Ivanov AV. Redox Biology of Respiratory Viral Infections. Viruses. 2018 Jul 26;10(8):392. doi: 10.3390/v10080392.
- Results publication: PubMed 28918004Liu M, Chen F, Liu T, Chen F, Liu S, Yang J. The role of oxidative stress in influenza virus infection. Microbes Infect. 2017 Dec;19(12):580-586. doi: 10.1016/j.micinf.2017.08.008. Epub 2017 Sep 14.
- Results publication: PubMed 30569652Agarwal A, Rana M, Qiu E, AlBunni H, Bui AD, Henkel R. Role of oxidative stress, infection and inflammation in male infertility. Andrologia. 2018 Dec;50(11):e13126. doi: 10.1111/and.13126.
- Results publication: PubMed 31285919Dutta S, Majzoub A, Agarwal A. Oxidative stress and sperm function: A systematic review on evaluation and management. Arab J Urol. 2019 Apr 24;17(2):87-97. doi: 10.1080/2090598X.2019.1599624. eCollection 2019.
- Results publication: PubMed 30893955Homa ST, Vassiliou AM, Stone J, Killeen AP, Dawkins A, Xie J, Gould F, Ramsay JWA. A Comparison Between Two Assays for Measuring Seminal Oxidative Stress and their Relationship with Sperm DNA Fragmentation and Semen Parameters. Genes (Basel). 2019 Mar 19;10(3):236. doi: 10.3390/genes10030236.
- Results publication: PubMed 15549175Kuhn JH, Li W, Choe H, Farzan M. Angiotensin-converting enzyme 2: a functional receptor for SARS coronavirus. Cell Mol Life Sci. 2004 Nov;61(21):2738-43. doi: 10.1007/s00018-004-4242-5.
- Results publication: PubMed 20674894Reis FM, Bouissou DR, Pereira VM, Camargos AF, dos Reis AM, Santos RA. Angiotensin-(1-7), its receptor Mas, and the angiotensin-converting enzyme type 2 are expressed in the human ovary. Fertil Steril. 2011 Jan;95(1):176-81. doi: 10.1016/j.fertnstert.2010.06.060. Epub 2010 Aug 1.
- Results publication: PubMed 32761294Wang J, Peng Y, Xu H, Cui Z, Williams RO 3rd. The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation. AAPS PharmSciTech. 2020 Aug 5;21(6):225. doi: 10.1208/s12249-020-01744-7.
- Results publication: PubMed 27104575Vartak A, Sucheck SJ. Recent Advances in Subunit Vaccine Carriers. Vaccines (Basel). 2016 Apr 19;4(2):12. doi: 10.3390/vaccines4020012.
- Individual participant dataSharing planned: Undecided. On request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fertility Issues and Vaccine Adverse Reaction, run by Sheba Medical Center at 1 site in Israel.
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 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 22 Jun 2023. 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 Israel. 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?
Delta in AMH levels (time frame: From first vaccination until the second AMH sampling - after three month). 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 NCT04748172, 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 22 Jun 2023.