Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid

• Conditions: SARS-CoV-2
• Interventions: Diagnostic Test: Anti COVID19 IgG Antibodies

• Registration Number: NCT04822012
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-28
• Last Update Submitted: 2021-03-28
• Study First Posted: 2021-03-30
• Last Update Posted: 2021-03-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female	Anti COVID19 IgG Antibodies	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.
Male	Anti COVID19 IgG Antibodies	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.

Primary Outcome Measures

Name	Time	Method
Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio	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
Spermatic fluid- Serum Anti COVID-19 antibody (Immunoglobulin G) ratio	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

Secondary Outcome Measures

Name	Time	Method
Follicular fluid Estradiol level (pmol/L)	Through study completion, expected 2 months	Quality assessment of follicular fluid as measured by Estradiol level
Follicular fluid Progesterone level (nmol/L)	Through study completion, expected 2 months	Quality assessment of follicular fluid as measured by Progesterone level
Follicular fluid Perlecan level (nmol/L)	Through study completion, expected 2 months	Quality assessment of follicular fluid as measured by Perlecan level

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel