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

NCT04425317 | Completed

• 1 other identifier: COVIDOFF001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; COVID; IVF

Outcome Measures

Primary Outcomes (1)

• Presence or absence of SARS-CoV-2 in follicular fluid, cumulus cells, immature oocytes and endometrium

  Identification of viral RNA in cumulus-oocyte-complexes, exclusively looking at the material that is considered waste material in a normal oocyte retrieval

  1 day

Secondary Outcomes (1)

• Presence of ACE2, TMPRSS and BSG receptors in cumulus cells, immature oocytes and endometrium

  1 day

Study Arms (1)

Diagnostic arm

OTHER

Blood sample and endometrial biopsy Collection of follicular fluid, immature oocytes and cumulus cells

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Blood sample and endometrial biopsy on the moment of oocyte retrieval

Also known as: Endometrial biopsy

Diagnostic arm

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Undergoing IVF/ICSI treatment
• Planned for an oocyte retrieval
• PCR positive of SARS-CoV-2 or high suspicion for COVID 19 based on CT scan
• Signed informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• CRG UZ Brussel: lead

Study Sites (1)

Uz Brussels

Brussels, 1090, Belgium

Location

Related Publications (2)

• Hou R, Huang R, Zhou Y, Lin D, Xu J, Yang L, Wei X, Xie Z, Zhou Q. Single-cell profiling of the microenvironment in decidual tissue from women with missed abortions. Fertil Steril. 2023 Mar;119(3):492-503. doi: 10.1016/j.fertnstert.2022.12.016. Epub 2022 Dec 15.

  PMID: 36528108 DERIVED

• Boudry L, Essahib W, Mateizel I, Van de Velde H, De Geyter D, Pierard D, Waelput W, Uvin V, Tournaye H, De Vos M, De Brucker M. Undetectable viral RNA in follicular fluid, cumulus cells, and endometrial tissue samples in SARS-CoV-2-positive women. Fertil Steril. 2022 Apr;117(4):771-780. doi: 10.1016/j.fertnstert.2021.12.032. Epub 2022 Jan 1.

  PMID: 35272846 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 11, 2020
• Study Start: September 10, 2020
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)