Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid

SARS-CoV-2 Clinical Trial

Official title:

Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822012
• Other study ID #: 0053-21-HMO
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2021
• Source: Meir Medical Center
• Contact: Daniela Hoffman
• Phone: +97226777242
• Email: danielho[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: April 30, 2021
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Batiha O, Al-Deeb T, Al-Zoubi E, Alsharu E. Impact of COVID-19 and other viruses on reproductive health. Andrologia. 2020 Oct;52(9):e13791. doi: 10.1111/and.13791. Epub 2020 Aug 13. Review. — View Citation

Segars J, Katler Q, McQueen DB, Kotlyar A, Glenn T, Knight Z, Feinberg EC, Taylor HS, Toner JP, Kawwass JF; American Society for Reproductive Medicine Coronavirus/COVID-19 Task Force. Prior and novel coronaviruses, Coronavirus Disease 2019 (COVID-19), and human reproduction: what is known? Fertil Steril. 2020 Jun;113(6):1140-1149. doi: 10.1016/j.fertnstert.2020.04.025. Epub 2020 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Follicular fluid Estradiol level (pmol/L)	Quality assessment of follicular fluid as measured by Estradiol level	Through study completion, expected 2 months
Secondary	Follicular fluid Progesterone level (nmol/L)	Quality assessment of follicular fluid as measured by Progesterone level	Through study completion, expected 2 months
Secondary	Follicular fluid Perlecan level (nmol/L)	Quality assessment of follicular fluid as measured by Perlecan level	Through study completion, expected 2 months