NCT04425317: COVID_OFF

Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients

Completed NA Last updated 17 February 2022

What this trial tests

NA trial testing Blood sample in Infertility in 16 participants. Completed in 1 January 2022.

Timeline

10 September 2020

Primary endpoint
1 June 2021

1 January 2022

Quick facts

Lead sponsor	CRG UZ Brussel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	10 September 2020
Primary completion	1 June 2021
Estimated completion	1 January 2022
Sites	1 location across Belgium

Drugs / interventions tested

• Blood sample — full drug profile →

Conditions studied

• Infertility — all drugs for Infertility →
• COVID — all drugs for COVID →
• IVF — all drugs for IVF →

Sponsor

CRG UZ Brussel — full company profile →

Who can join

Under 45, female only, with Infertility or COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recently, the world was shaken awake by a pandemic caused by a novel coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). In most nations drastic isolation measures were taken to minimize the further spread of the Coronavirus Disease 2019 (COVID-19). Being the first pandemic sparked by a Coronavirus, little was known on COVID-19 and its implications on general health. Our understanding on the virus and its potential effects on health is growing. In Belgium, the situation is stabilizing, and doctors and healthcare workers are slowly recommencing routine work and consultations. As also fertility treatments were abruptly interrupted, many patients are in need to resume their treatment. The limited evidence of SARS-CoV-2 on pregnancy seems to be rather satisfying1, but practically nothing is known about the possible impact of an active SARS-CoV-2 infection on female gametes. Viral transmission occurs predominantly through respiratory droplets, but transmission to gametes cannot be ruled out.

Since the onset of the pandemic, knowledge about the molecular details of SARS-CoV-2 infection rapidly grew. Coronaviruses are enveloped RNA viruses. For a virus to deliver their genome into the host cell, attachment and entrance into that cell is a crucial step. The coronavirus surface protein spike (S) mediates entry into target cells by binding to a cellular receptor and subsequent fusing of the viral envelope with a host cell membrane. The SARS-CoV-2-S protein (SARS-S) utilizes angiotensin-converting enzyme 2 (ACE2) as a receptor for host cell entry. Host proteases such as transmembrane serine protease 2 (TMPRSS2) are then needed to cleave the viral S protein, allow-ing permanent fusion of the viral and host cell membranes2. Expression of ACE2 and TMPRSS2 has been shown in testicular, uterine and placental cells. Based on available transcriptomic data, co-expression of ACE2 and TMPRSS2 is also seen on oocyte level, but the possible impact on reproduction is unknown. The BSG (basigin or CD147), a receptor on host cells, was also identified as a possible route for viral invasion.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Undetectable viral RNA in follicular fluid, cumulus cells, and endometrial tissue samples in SARS-CoV-2-positive women.
   Boudry L, Essahib W, Mateizel I, Van de Velde H, et al · · 2022 · cited 30× · PMID 35272846 · DOI 10.1016/j.fertnstert.2021.12.032
2. Single-cell profiling of the microenvironment in decidual tissue from women with missed abortions.
   Hou R, Huang R, Zhou Y, Lin D, et al · · 2023 · cited 16× · PMID 36528108 · DOI 10.1016/j.fertnstert.2022.12.016
3. P–274 Undetectable viral RNA in follicular fluid (FF), cumulus cells (CC) and endometrial tissue in SARS-CoV–2 positive patients
   Boudry L, Essahib W, Mateizel I, Va. d. Velde H, et al · · 2021