Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT04822012
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Follicular fluid post egg retreival and spermatic fluid post fertilization'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-28', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-28', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follicular - Serum Anti COVID-19 antibody (Immunoglobulin G) ratio', 'timeFrame': 'Through study completion, expected 2 months', 'description': 'The relationship between antibodies to COVID-19 in serum to follicular fluid in female patients going through an egg retrieval'}, {'measure': 'Spermatic fluid- Serum Anti COVID-19 antibody (Immunoglobulin G) ratio', 'timeFrame': 'Through study completion, expected 2 months', 'description': 'The relationship between antibodies to COVID-19 in serum to spermatic fluid in male patients going through in vitro fertilization treatment'}], 'secondaryOutcomes': [{'measure': 'Follicular fluid Estradiol level (pmol/L)', 'timeFrame': 'Through study completion, expected 2 months', 'description': 'Quality assessment of follicular fluid as measured by Estradiol level'}, {'measure': 'Follicular fluid Progesterone level (nmol/L)', 'timeFrame': 'Through study completion, expected 2 months', 'description': 'Quality assessment of follicular fluid as measured by Progesterone level'}, {'measure': 'Follicular fluid Perlecan level (nmol/L)', 'timeFrame': 'Through study completion, expected 2 months', 'description': 'Quality assessment of follicular fluid as measured by Perlecan level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infertility; SARS-CoV-2,COVID-19'], 'conditions': ['SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '32790205', 'type': 'BACKGROUND', '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.'}, {'pmid': '32482250', 'type': 'BACKGROUND', '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.'}, {'pmid': '34364311', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned egg retrieval procedure (including egg preservation)\n* Negative PCR for SARS-Cov-19 in the week before egg retrival\n* Informed consent\n\nExclusion Criteria:\n\n* Positive PCR for SARS-Cov-19 in the week before egg retrival\n* expected retrival of 1-3 eggs'}, 'identificationModule': {'nctId': 'NCT04822012', 'briefTitle': 'Anti COVID-19 Antibodies in Follicular Fluid and Spermatic Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Anti COVID-19 Antibodies in Spermatic Fluid and Follicular Fluid', 'orgStudyIdInfo': {'id': '0053-21-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female', 'description': '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.', 'interventionNames': ['Diagnostic Test: Anti COVID19 IgG Antibodies']}, {'label': 'Male', 'description': '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.', 'interventionNames': ['Diagnostic Test: Anti COVID19 IgG Antibodies']}], 'interventions': [{'name': 'Anti COVID19 IgG Antibodies', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Estrogen and Progesterone levels in serum and follicle', 'Follicular Perlecan level'], 'description': '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', 'armGroupLabels': ['Female', 'Male']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Anat Hershko Klement, MD', 'role': 'CONTACT', 'email': 'anat.klement@gmail.com', 'phone': '972549170084'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Daniela Hoffman', 'role': 'CONTACT', 'email': 'danielho@hadassah.org.il', 'phone': '+97226777242'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Unit director', 'investigatorFullName': 'Anat Hershko Klement', 'investigatorAffiliation': 'Meir Medical Center'}}}}