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COVID-19 Infection and Reproductive Health in Infertile Women

Post-COVID-19 Infection and Reproductive Health in Women Undergoing I.V.F. Treatment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05435430
Acronym
COVINF
Enrollment
150
Registered
2022-06-28
Start date
2022-09-01
Completion date
2024-03-01
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Keywords

SARS COV 19,IVF,OVARINA RESERVE,PREGNANCY

Brief summary

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.

Detailed 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).

Interventions

OTHERPERSPECTIVE, MULTICENTRIC and observational

we will enroll women with 25-45ys old and previously SARS-COV2 infection. first outcome to be investigate the impact of SARS-COV2 infection on female reproductive health and the main clinical-laboratory parameters (FSH, LH, AMH) relating to women with procreative research, in a path of medically procreation assisted programm and on any quantitative variations, duration and periodicity of the menstrual cycle after Covid infection compared to the pre-infection period.

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Main outcome18 monthsTo investigate how the SARS-COV2 infection affects the female reproductive health and the main clinical-laboratory parameters (FSH, LH, AMH) relating to women with procreative research in a path of medically assisted procreation and any quantitative variations, duration and periodicity of the menstrual cycle after Covid infection.19 compared to the pre-infection period.

Secondary

MeasureTime frameDescription
secondary outcomes18 monthsQuantification of the number of good quality oocytes (MII) . Number of embryos on day 3 (Morula) or day 5 (blastocyst) of development transferred to the patients. Thickness of the endometrium at the time of embryo transfer (ET).

Countries

Italy

Contacts

Primary ContactGiuseppe Gullo, MD.Ph.D
gullogiuseppe@libero.it+393336103998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026