Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid

March 28, 2021 updated by: Anat Hershko Klement, Meir Medical Center

Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid

Patients going through an in vitro fertilization cycle will be asked to participate . Patients will be asked for their COVID-19 exposure : post confirmed disease/post vaccine/not exposed to disease or vaccine . Patients will provide the fluids which are not required , once fertilization process is completed. Patients will also provide 5ml blood sample by the day of procedure. Anti COVID-19 immunoglobulin G type antibodies will be measured in all samples . Data regarding age, date of infection/vaccine will be collected . Progesterone and Estrogen will be measured in female patients' samples and Perlecan level will be measured in follicular fluid.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients going through an in vitro fertilization cycle will be asked to participate . Patients will be asked for their COVID-19 exposure : post confirmed disease/post vaccine/not exposed to disease or vaccine . Patients will provide the fluids which are not required in the day of egg retrieval : the follicular fluid remaining after isolation of the egg and spermatic fluid only, if not utilized for fertilization. The fluids will be collected once fertilization process is completed. Patients will also provide 5ml blood sample by the day of procedure. Anti COVID-19 immunoglobulin G type antibodies will be measured in all samples . Data regarding age, date of infection/vaccine will be collected as well as indication for treatment, Estradiol level before the egg retrieval, number of eggs collected and the triggering ovulation modality . Progesterone and Estrogen will be measured in female patients' samples (follicular fluid and serum). Perlecan level will be measured in follicular fluid.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients going through an artificial reproductive procedure : females performing egg retrieval and males performing in vitro fertilization with their female partner. Each addressed separately for informed consent.

Description

Inclusion Criteria:

  • Planned egg retrieval procedure (including egg preservation)
  • Negative PCR for SARS-Cov-19 in the week before egg retrival
  • Informed consent

Exclusion Criteria:

  • Positive PCR for SARS-Cov-19 in the week before egg retrival
  • expected retrival of 1-3 eggs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Female
Female patients going through an egg retrival procedure and were identified as post COVID-19 vaccine/ post COVIS-19 infection or not post vaccine/post disease and screened negative for COVID-19 in the week prior to the procedure.
Diagnostic test: Anti COVID19 IgG Antibodies
Detection of antibodies to SARS Cov 19 post infection or vaccination , measurements of female hormones in folicular fluid as compared to serum and Perlecan as a follicular quality marker
Other Names:
  • Estrogen and Progesterone levels in serum and follicle
  • Follicular Perlecan level
Male
male patients going through an in vitro fertilization cycle and were identified as post COVID-19 vaccine/ post COVIS-19 infection or not post vaccine/post disease and screened negative for COVID-19 in the week prior to the procedure.
Diagnostic test: Anti COVID19 IgG Antibodies
Detection of antibodies to SARS Cov 19 post infection or vaccination , measurements of female hormones in folicular fluid as compared to serum and Perlecan as a follicular quality marker
Other Names:
  • Estrogen and Progesterone levels in serum and follicle
  • Follicular Perlecan level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio
Time Frame: Through study completion, expected 2 months
The relationship between antibodies to COVID-19 in serum to follicular fluid in female patients going through an egg retrieval
Through study completion, expected 2 months
Spermatic fluid- Serum Anti COVID-19 antibody (Immunoglobulin G) ratio
Time Frame: Through study completion, expected 2 months
The relationship between antibodies to COVID-19 in serum to spermatic fluid in male patients going through in vitro fertilization treatment
Through study completion, expected 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicular fluid Estradiol level (pmol/L)
Time Frame: Through study completion, expected 2 months
Quality assessment of follicular fluid as measured by Estradiol level
Through study completion, expected 2 months
Follicular fluid Progesterone level (nmol/L)
Time Frame: Through study completion, expected 2 months
Quality assessment of follicular fluid as measured by Progesterone level
Through study completion, expected 2 months
Follicular fluid Perlecan level (nmol/L)
Time Frame: Through study completion, expected 2 months
Quality assessment of follicular fluid as measured by Perlecan level
Through study completion, expected 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 28, 2021

First Posted (ACTUAL)

March 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0053-21-HMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SARS-CoV-2

Clinical Trials on Anti COVID19 IgG Antibodies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe