Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?

Fertility Disorders Clinical Trial

Official title:

Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05489367
• Other study ID #: GaziosmanpasaTREHm
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2022
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 30, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• between 18-45 years old

• have ever had a covid vaccine

• not be infected with covid 19

Exclusion Criteria:

• pregnancy

• diagnosis of any kind of cancer

• oral contraceptive usage

• endometrioma

• PCOS

• menopause

• menstrual irregularity

• premature ovarian insufficiency

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Virus Infection
• Fertility Disorders
• Ovarian Function Insufficiency
• Vaccine Adverse Reaction

Intervention

Biological:
• sars cov 2 biontec vaccine
volunteers will be expected to receive 2 doses of vaccine

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Training and Research Hospital	Istanbul	Gaziosmanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian reserve tests and fertility status of 74 women before and after vaccination	before and after vaccination serum Amh level ng/ml	6 months after receiving the 2nd dose of vaccine
Secondary	AMH difference between vaccinated and unvaccinated groups	AMH difference between vaccinated and unvaccinated groups	6 months