NCT04748172

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

February 6, 2021

Last Update Submit

June 19, 2023

Conditions

Fertility IssuesVaccine Adverse Reaction

Keywords

Ovarian reserveCorona-19 virusSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Delta in AMH levels

    AMA levels on recruitment minos AMH levels after three months

    From first vaccination until the second AMH sampling - after three month

Study Arms (1)

Study Group: Women who are planning to be vaccinated

Women that are planning to be vaccinated, before receiving the first shot of the vaccine

Biological: SARS-CoV-2 virus vaccinesDiagnostic Test: AMH samplingDiagnostic Test: anti Covid-19 antibody levels (Serology)

Interventions

SARS-CoV-2 virus vaccinesBIOLOGICAL

mRNA SARS-CoV-2 virus vaccines ( By Pfizer or Moderna)

Study Group: Women who are planning to be vaccinated
AMH samplingDIAGNOSTIC_TEST

Blood sample for AMH on recruitment and after three months

Study Group: Women who are planning to be vaccinated
anti Covid-19 antibody levels (Serology)DIAGNOSTIC_TEST

Blood sample for IgG against S1 protein after three months

Study Group: Women who are planning to be vaccinated

Eligibility Criteria

Age11 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in reproductive age
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Females (age 11 to 42) that are planning to be vaccinated in Israel

You may qualify if:

  • Age 11-42
  • No previous exposure to Covid-19 vaccine (first or second dose)
  • No known past Covid-19 infection

You may not qualify if:

  • Premature ovarian failure
  • Pregnancy
  • Fertility treatment
  • Past Covid-19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 56506, Israel

Location

Related Publications (14)

  • 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.

    PMID: 32466995RESULT

  • Joguet 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.

    PMID: 28838639RESULT

  • Percivalle E, Zavattoni M, Fausto F, Rovida F. Zika virus isolation from semen. New Microbiol. 2017 Jul;40(3):197-198. Epub 2017 May 17.

    PMID: 28513814RESULT

  • Khomich OA, Kochetkov SN, Bartosch B, Ivanov AV. Redox Biology of Respiratory Viral Infections. Viruses. 2018 Jul 26;10(8):392. doi: 10.3390/v10080392.

    PMID: 30049972RESULT

  • Liu 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.

    PMID: 28918004RESULT

  • Agarwal 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.

    PMID: 30569652RESULT

  • Dutta 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.

    PMID: 31285919RESULT

  • Homa 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.

    PMID: 30893955RESULT

  • Kuhn 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.

    PMID: 15549175RESULT

  • Reis 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.

    PMID: 20674894RESULT

  • Wang 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.

    PMID: 32761294RESULT

  • Vartak A, Sucheck SJ. Recent Advances in Subunit Vaccine Carriers. Vaccines (Basel). 2016 Apr 19;4(2):12. doi: 10.3390/vaccines4020012.

    PMID: 27104575RESULT

  • Mohr-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.

    PMID: 36871101DERIVED

  • Mohr-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.

    PMID: 34935913DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples evaluated for Anti Mullarian Hormone (AMH)

MeSH Terms

Conditions

Infertility

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 10, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

IL(1)