MedDataX Logo

Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid

NCT ID: NCT04822012

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

infertility; SARS-CoV-2,COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Anti COVID19 IgG Antibodies

Intervention Type DIAGNOSTIC_TEST

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

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.

Anti COVID19 IgG Antibodies

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Estrogen and Progesterone levels in serum and follicle Follicular Perlecan level

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anat Hershko Klement

Unit director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniela Hoffman

Role: CONTACT

Phone: +97226777242

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anat Hershko Klement, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32790205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32482250 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34364311 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0053-21-HMO

Identifier Type: -

Identifier Source: org_study_id