Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 9:49 PM
Study NCT ID:
NCT05305027
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Sequential βHCG in IVF Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth incidence per serum βHCG value', 'timeFrame': '1 year', 'description': 'Compare the incidence of Live Birth according to serum βHCG (IU/L) measurement in all patients undergoing ART procedures.'}], 'secondaryOutcomes': [{'measure': 'Comparison of live birth incidence with serum βHCG confounders', 'timeFrame': '1 year', 'description': 'Comparison of live birth incidence according to possible risk factors for serum βHCG (IU/L) measurements, among patients undergoing ART procedures.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Early']}, 'referencesModule': {'references': [{'pmid': '16753158', 'type': 'BACKGROUND', 'citation': 'Seeber BE, Sammel MD, Guo W, Zhou L, Hummel A, Barnhart KT. Application of redefined human chorionic gonadotropin curves for the diagnosis of women at risk for ectopic pregnancy. Fertil Steril. 2006 Aug;86(2):454-9. doi: 10.1016/j.fertnstert.2005.12.056. Epub 2006 Jun 6.'}, {'pmid': '31758302', 'type': 'RESULT', 'citation': 'Wang Z, Gao Y, Zhang D, Li Y, Luo L, Xu Y. Predictive value of serum beta-human chorionic gonadotropin for early pregnancy outcomes. Arch Gynecol Obstet. 2020 Jan;301(1):295-302. doi: 10.1007/s00404-019-05388-2. Epub 2019 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'Early diagnosis of pregnancy with its localization and evolution has always been one of the major objectives of gynecology and obstetrics, even more so in Artificial Reproductive Technology (ART) centers.\n\nThe pivotal test is the βHCG assay. Various protocols have been proposed over the years, including single assessment and serial assays.\n\nSeveral studies in the past years have tried to define a cut-off predictive of a successful pregnancy.\n\nAbnormal levels of βHCG are associated with biochemical pregnancies, non-viable pregnancies and ectopic pregnancies (EP). The efficacy of a single serum βHCG test to predict EP is low and a significant amount of time and resources are spent diagnosing it.\n\nIn recent studies, better sensitivity was obtained from the ratio of two successive time points of βHCG concentration, with better specificity instead from regression models. These proposed models however lack validation and require further improvement.', 'detailedDescription': 'Fertility clinics follow different protocols for the measurement of βHCG. Typically the initial serum measurement is performed 10-12 days after blastocyst transfer or 12-14 days after transfer at cleavage stage. Often a second serum measurement of hCG is performed at 48h since an increase of at least 50% is known to be a good predictor of ongoing pregnancy.\n\nThe doubling time was first described in natural pregnancies where the rate of βHCG rise was reported to be at least 53% in two days, with a median of 50% increase at day 1 and 124% at day 2. Following the first detection and rise of serum βHCG, it is possible to predict earlier than with transvaginal ultrasound non-viable pregnancies, ectopic pregnancies, biochemical pregnancies and spontaneous abortion or reassure the couple when these values are representative of an ongoing pregnancy (OP). Conversely, however, many studies have found different thresholds of βHCG to be representative of OP, with many women under the cut-off value ending up having a normal pregnancy.\n\nThe variability within the threshold expresses the need for a better biological marker or cut-off value. Implementing patient characteristics in a model to redefine and personalize the cut-off is necessary to improve pregnancy detection and management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include retrospectively all patients that underwent IVF cycles (including fresh and thawed embryo transfers) between January 2011 and December 2020 at a Third level University-affiliated center, Humanitas Fertility Center in (Rozzano, MI).\n\nThe internal database (Art-it) will be used to retrieve data on age, body mass index (BMI), baseline sex hormone levels, main causes of infertility, endometrial thickness, details of stimulation protocols, date of insemination, date of embryo transfer, number of embryos transferred, date of βHCG examination, serum concentrations of βHCG, fertilization results, pregnancy types (EP, biochemical pregnancy, intrauterine)', 'healthyVolunteers': False, 'eligibilityCriteria': 'All women that underwent IVF cycles (including fresh and thawed embryo transfers) between January 2011 and December 2020.'}, 'identificationModule': {'nctId': 'NCT05305027', 'briefTitle': 'Predictive Value of Sequential βHCG in IVF Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Single-centre Retrospective Study on the Predictive Value of Sequential Early βHCG Measurements in IVF Pregnancies.', 'orgStudyIdInfo': {'id': '21012021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVF patients: first serum βHCG', 'description': 'IVF patients who undergo βHCG after fresh or frozen embryo transfer', 'interventionNames': ['Behavioral: Prompt diagnois pregnancy outcome']}], 'interventions': [{'name': 'Prompt diagnois pregnancy outcome', 'type': 'BEHAVIORAL', 'armGroupLabels': ['IVF patients: first serum βHCG']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paolo Emanuele Levi Setti, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Research Administration Manager and Head of Clinical Trial Office Humanitas Clinical and Research Center', 'investigatorFullName': 'Michele Tedeschi', 'investigatorAffiliation': 'Istituto Clinico Humanitas'}}}}