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:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
Single-centre Retrospective Study on the Predictive Value of Sequential Early βHCG Measurements in IVF Pregnancies.
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
The pivotal test is the βHCG assay. Various protocols have been proposed over the years, including single assessment and serial assays.
Several studies in the past years have tried to define a cut-off predictive of a successful pregnancy.
Abnormal 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.
In 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.
The pivotal test is the βHCG assay. Various protocols have been proposed over the years, including single assessment and serial assays.
Several studies in the past years have tried to define a cut-off predictive of a successful pregnancy.
Abnormal 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.
In 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.
Detailed Description:
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.
The 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.
The 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.
The 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.
The 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: