COVID-19 Virus InfectionNCT05489367
Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
An observational study of COVID-19 Virus Infection and Ovarian Function Insufficiency, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Virus Infection, Ovarian Function Insufficiency, Fertility Disorders
- What is being tested?
- sars cov 2 biontec vaccine
- Type of treatment
- Vaccines
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Nov 2022
- How long will I take part?
- 8 Months
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 74 ovulatory women who were not vaccinated with Biontech.
Who may be able to join
- between 18-45 years old
- have ever had a covid vaccine
- not be infected with covid 19
Who cannot join
- pregnancy
- diagnosis of any kind of cancer
- oral contraceptive usage
- endometrioma
- PCOS
- menopause
- menstrual irregularity
- premature ovarian insufficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 32225
About this study
Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination
Read the detailed description
our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded.
the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.
- Conditions
- COVID-19 Virus Infection, Ovarian Function Insufficiency, Fertility Disorders, Vaccine Adverse Reaction
- Being tested
- sars cov 2 biontec vaccine
- Keywords
- ovarian reserve, covid-19, vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sars cov 2 biontec vaccineBiological
volunteers will be expected to receive 2 doses of vaccine
| Study group | Role | What they receive |
|---|---|---|
| Pre-vaccine ovarian reserve and fertility status | Before vaccination, ovarian reserve tests and fertility status of 64 women will be examined and results will be recorded.After 2 doses of vaccination, ovarian reserve and fertility status of same 64 women will be examined and results will be recorded Receives: Biological: sars cov 2 biontec vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve tests and fertility status of 74 women before and after vaccination
before and after vaccination serum Amh level ng/ml
Measured: 6 months after receiving the 2nd dose of vaccine
Secondary outcomes (1)
AMH difference between vaccinated and unvaccinated groups
AMH difference between vaccinated and unvaccinated groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Feb 2022
- Primary completion20 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Virus InfectionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Yıldız, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489367
- Sponsor's protocol ID
- GaziosmanpasaTREHm
- Status last verified
- Aug 2022
- First submitted
- 30 Jan 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No: A number will be given to each volunteer who agrees to participate in the study.All data obtained will be recorded in this number and all data will be stored on the personal computer of the researcher.No personal data will be shared with anyone other than the study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
- ClinicalTrials.gov ID
- NCT05489367
- Acronym / sponsor ID
- GaziosmanpasaTREHm
- Conditions
- COVID-19 Virus Infection, Ovarian Function Insufficiency, Fertility Disorders, Vaccine Adverse Reaction
- Keywords
- ovarian reserve, covid-19, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Aug 2022 (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.
Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination
Detailed description
our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded.
the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-vaccine ovarian reserve and fertility status | – | Biological: sars cov 2 biontec vaccineBefore vaccination, ovarian reserve tests and fertility status of 64 women will be examined and results will be recorded.After 2 doses of vaccination, ovarian reserve and fertility status of same 64 women will be examined and results will be recorded |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 74 ovulatory women who were not vaccinated with Biontech.
Key inclusion criteria (3 listed)
- between 18-45 years old
- have ever had a covid vaccine
- not be infected with covid 19
Key exclusion criteria (8 listed)
- pregnancy
- diagnosis of any kind of cancer
- oral contraceptive usage
- endometrioma
- PCOS
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 biontec vaccinevolunteers will be expected to receive 2 doses of vaccine | Biological | Pre-vaccine ovarian reserve and fertility status |
Primary outcome
Ovarian reserve tests and fertility status of 74 women before and after vaccination
Time frame: 6 months after receiving the 2nd dose of vaccine
before and after vaccination serum Amh level ng/ml
1 secondary outcome
AMH difference between vaccinated and unvaccinated groups
Time frame: 6 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 Feb 2023.
- Individual participant dataSharing planned: No. A number will be given to each volunteer who agrees to participate in the study.All data obtained will be recorded in this number and all data will be stored on the personal computer of the researcher.No personal data will be shared with anyone other than the study.
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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 COVID-19 Virus Infection and Ovarian Function Insufficiency, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 8 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 Feb 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 Turkey (Türkiye). 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?
Ovarian reserve tests and fertility status of 74 women before and after vaccination (time frame: 6 months after receiving the 2nd dose of vaccine). 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 22 Feb 2023.