Clinical trial NCT04822012: Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid
Official title: Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Keywords: infertility; SARS-CoV-2,COVID-19
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio
timeFrame: Through study completion, expected 2 months
measure: Spermatic fluid- Serum Anti COVID-19 antibody (Immunoglobulin G) ratio
timeFrame: Through study completion, expected 2 months
Secondary outcomes:
measure: Follicular fluid Estradiol level (pmol/L)
timeFrame: Through study completion, expected 2 months
measure: Follicular fluid Progesterone level (nmol/L)
timeFrame: Through study completion, expected 2 months
measure: Follicular fluid Perlecan level (nmol/L)
timeFrame: Through study completion, expected 2 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
citation: 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.
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.
citation: Bentov Y, Beharier O, Moav-Zafrir A, Kabessa M, Godin M, Greenfield CS, Ketzinel-Gilad M, Ash Broder E, Holzer HEG, Wolf D, Oiknine-Djian E, Barghouti I, Goldman-Wohl D, Yagel S, Walfisch A, Hersko Klement A. Ovarian follicular function is not altered by SARS-CoV-2 infection or BNT162b2 mRNA COVID-19 vaccination. Hum Reprod. 2021 Aug 18;36(9):2506-2513. doi: 10.1093/humrep/deab182.