- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822012
Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid
March 28, 2021 updated by: Anat Hershko Klement, Meir Medical Center
Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniela Hoffman
- Phone Number: +97226777242
- Email: danielho@hadassah.org.il
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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
Other Names:
|
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio
Time Frame: 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
|
Through study completion, expected 2 months
|
Spermatic fluid- Serum Anti COVID-19 antibody (Immunoglobulin G) ratio
Time Frame: 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
|
Through study completion, expected 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Follicular fluid Estradiol level (pmol/L)
Time Frame: Through study completion, expected 2 months
|
Quality assessment of follicular fluid as measured by Estradiol level
|
Through study completion, expected 2 months
|
Follicular fluid Progesterone level (nmol/L)
Time Frame: Through study completion, expected 2 months
|
Quality assessment of follicular fluid as measured by Progesterone level
|
Through study completion, expected 2 months
|
Follicular fluid Perlecan level (nmol/L)
Time Frame: Through study completion, expected 2 months
|
Quality assessment of follicular fluid as measured by Perlecan level
|
Through study completion, expected 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2021
Primary Completion (ANTICIPATED)
April 30, 2021
Study Completion (ANTICIPATED)
June 1, 2021
Study Registration Dates
First Submitted
March 26, 2021
First Submitted That Met QC Criteria
March 28, 2021
First Posted (ACTUAL)
March 30, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 28, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Progestins
- Antibodies
- Progesterone
- Immunoglobulin G
- Estrogens
Other Study ID Numbers
- 0053-21-HMO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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