COVID-19 Infection and Reproductive Health in Infertile Women (COVINF)

U

University of Palermo

Status

Enrolling

Conditions

Infertility, Female

Treatments

Other: PERSPECTIVE, MULTICENTRIC and observational

Study type

Observational

Funder types

Other

Identifiers

NCT05435430
AOOR VILLA SOFIA CERVELLO

Details and patient eligibility

About

An increased number of women has been infected by COVID-19 in the last 2 years SARS-CoV-2 infection could have a role in potential disturbances on hormon levels and human fertility Has not completely demonstrated COVID-19 effects on female reproductive function and further research can be undertaken. The proposed multicenter study will be simple and rapid, and attractive for the scientific community.

Full description

COVID-19 virus is classified as a respiratory disease that drastically changed our daily life and perspective (1) can be mainly transmitted via respiratory droplets, however, there are recently published reports suggested its ability to transmit via sexual intercourse, assisted reproductive technology (ART) treatments, pregnancy, and nursing. ART specialists should be precautious, carefully following the situation while contributing by sharing novel evidence to counsel our patients (2). However, there are no comprehensive reviews to explore the association between COVID-19 and female fertility comprehensively.Its of major importance to provide in-depth research explaining the underlying mechanism of SARS-CoV-2 infection and its impact on human reproductive organs and fertility (3). Ovarian reserve is a key determinant of female fertility. In this study we observe the potential effects of SARS-CoV-2 infection on the principal indicators of ovarian reserve function as anti-Müllerian hormone (AMH); basal follicle-stimulating hormone (FSH), basal luteinising hormone (LH) basal oestradiol (E2) antral follicle count (AFC). Questions regarding the potential risks of sexual transmission during intercourse and/or application of ART, vertical transmission (throughout pregnancy, delivery, and breastfeeding), the health of pregnant and postpartum women, and fetal or postnatal health problems of neonates/children remain largely unanswered (4,5).

Enrollment

150 estimated patients

Sex

Female

Ages

25 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women 24-43 years of age Previous history of COVID-19 infection INFERTILITY DIAGNOSIS

Exclusion criteria

Women with current symptoms of COVID-19 infection Positive for HIV or the presence of active viral hepatitis Previosuly ovarian cancer, removal of ovaries or gonadotoxic treatments

Trial design

150 participants in 1 patient group

women with previously SARS-COV2 infection.
Description:
2 group from 2 IVF CENTER with egual criteria : INCLUSION CRITERIA: Women 24-43 years of age Previous history of COVID-19 infection INFERTILITY DIAGNOSIS ESCLUSION CRITERIA: women with current symptoms of COVID-19 infection Positive for HIV or the presence of active viral hepatitis Previosuly ovarian cancer, removal of ovaries or gonadotoxic treatments
Treatment:
Other: PERSPECTIVE, MULTICENTRIC and observational

Trial contacts and locations

1

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Central trial contact

Giuseppe Gullo, MD.Ph.D

Data sourced from clinicaltrials.gov

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