Patient ParticipationIsraelNCT05034679
Impact of Corona Vaccination on AMH- Anti Mullerian Hormone
An observational study of Patient Participation, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Since December 2020 Nationwide anti-COVID-19 vaccination began in Israel using the Pfizer - BioNtech vaccine (BNT162b2 mRNA). The vaccination campaign has been associated with concerns regarding potential detrimental effects on future fertility. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Participation
- What is being tested?
- Vcinated
- Type of treatment
- Vaccines
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2021to 15 Oct 2022
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who are going through IVF treatments.
Who may be able to join
- Age 18-44
Who cannot join
- Age over 45
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon, 58100
Eran Horowitz, M.D, 972-3-5028105, eranh7@gmail.com
Eran Horowitz, M.D
About this study
Official title: Wether Corona Vaccination Has Negative Impact on AMH- Anti Mullerian Hormone Which Express Ovarin Function
Since December 2020 Nationwide anti-COVID-19 vaccination began in Israel using the Pfizer - BioNtech vaccine (BNT162b2 mRNA). The vaccination campaign has been associated with concerns regarding potential detrimental effects on future fertility. The aim of the study is to determine the impact of COVID-19 vaccination on n AMH- Anti Mullerian Hormone which express ovarin function.
disease and/or immunization on human follicular function, by comparing follicular steroidogenesis, response to the LH/hCG trigger, and oocyte quality biomarker (HSPG2), in the aspirated follicular fluid of patients undergoing ovum pick-up.
Read the detailed description
Our assumption is that there is no effect of the vaccination on the AMH level. We plan to recruit 90 patients who are divided to three groups First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. Second group patients who were infected by Covid-19 ant therefor were not vaccinated to compare the AMH level before and after the infectious. The third group patients who were not infected and not vaccinated.
- Conditions
- Patient Participation
- Being tested
- Vcinated
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VcinatedBiological
Patients who were vacinated.
| Study group | Role | What they receive |
|---|---|---|
| Vaciinated | First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. Receives: Biological: Vcinated | |
| Infected patients by covid-19 and not vacinated | Second group patients who were infected by Covid-19 ant therefor were not vaccinated | |
| Not infected nor vacinated | Ptients who who were not infected nor vacinated by Covid-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amh levels
Before and after vacination
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start15 Jul 2021
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ParticipationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eran Horowitz M.D., Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034679
- Sponsor's protocol ID
- 0013-21-WOMC
- Acronym
- Israel
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wether Corona Vaccination Has Negative Impact on AMH- Anti Mullerian Hormone Which Express Ovarin Function
- ClinicalTrials.gov ID
- NCT05034679
- Acronym / sponsor ID
- Israel / 0013-21-WOMC
- Conditions
- Patient Participation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 5 Sep 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.
Since December 2020 Nationwide anti-COVID-19 vaccination began in Israel using the Pfizer - BioNtech vaccine (BNT162b2 mRNA). The vaccination campaign has been associated with concerns regarding potential detrimental effects on future fertility. The aim of the study is to determine the impact of COVID-19 vaccination on n AMH- Anti Mullerian Hormone which express ovarin function.
disease and/or immunization on human follicular function, by comparing follicular steroidogenesis, response to the LH/hCG trigger, and oocyte quality biomarker (HSPG2), in the aspirated follicular fluid of patients undergoing ovum pick-up.
Detailed description
Our assumption is that there is no effect of the vaccination on the AMH level. We plan to recruit 90 patients who are divided to three groups First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. Second group patients who were infected by Covid-19 ant therefor were not vaccinated to compare the AMH level before and after the infectious. The third group patients who were not infected and not vaccinated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaciinated | – | Biological: VcinatedFirst group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. |
| Infected patients by covid-19 and not vacinated | – | –Second group patients who were infected by Covid-19 ant therefor were not vaccinated |
| Not infected nor vacinated | – | –Ptients who who were not infected nor vacinated by Covid-19. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who are going through IVF treatments.
Key inclusion criteria (1 listed)
- Age 18-44
Key exclusion criteria (1 listed)
- Age over 45
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 |
|---|---|---|
| VcinatedPatients who were vacinated. | Biological | Vaciinated |
Primary outcome
Amh levels
Time frame: 9 months
Before and after vacination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- 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.
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 Patient Participation, run by Wolfson 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 1 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 5 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Horowitz, M.D (+972-54-4991919, eranh7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amh levels (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.