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临床试验/NCT05435430
NCT05435430Unknown不适用

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

University of Palermo1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Main outcome

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Main outcome

时间窗: 18 months

To 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.

次要结局

  • secondary outcomes(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GIUSEPPE GULLO

GIUSEPPE GULLO MD. Ph.D

University of Palermo

研究点 (1)

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