Predictive Value of Sequential βHCG in IVF Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Early

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All women that underwent IVF cycles (including fresh and thawed embryo transfers) between January 2011 and December 2020.

Treatment and study plan

Prompt diagnois pregnancy outcome

Behavioral

Primary outcomes

Live birth incidence per serum βHCG value

Time frame: 1 year

Compare the incidence of Live Birth according to serum βHCG (IU/L) measurement in all patients undergoing ART procedures.

Secondary outcomes

Comparison of live birth incidence with serum βHCG confounders

Time frame: 1 year

Comparison of live birth incidence according to possible risk factors for serum βHCG (IU/L) measurements, among patients undergoing ART procedures.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Single-centre Retrospective Study on the Predictive Value of Sequential Early βHCG Measurements in IVF Pregnancies.

Important dates

Study start: 2011
Primary completion: 2020
Study completion: 2020
First posted: Mar 31, 2022
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed