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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Dietary Supplements

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