Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Anti COVID19 IgG Antibodies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female<br>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<br>* 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<br>* Other names: Follicular Perlecan level;|
| Male<br>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<br>* 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<br>* Other names: Follicular Perlecan level;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio | 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 | 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) | Quality assessment of follicular fluid as measured by Estradiol level | Through study completion, expected 2 months | 
| Follicular fluid Progesterone level (nmol/L) | Quality assessment of follicular fluid as measured by Progesterone level | Through study completion, expected 2 months | 
| Follicular fluid Perlecan level (nmol/L) | Quality assessment of follicular fluid as measured by Perlecan level | Through study completion, expected 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility; SARS-CoV-2,COVID-19