Predictive Value of Sequential βHCG in IVF Pregnancy

Pregnancy Early Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305027
• Other study ID #: 21012021
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Early

Intervention

Behavioral:
• Prompt diagnois pregnancy outcome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (2)

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. Epub 2006 Jun 6. — View Citation

Wang Z, Gao Y, Zhang D, Li Y, Luo L, Xu Y. Predictive value of serum ß-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth incidence per serum ßHCG value	Compare the incidence of Live Birth according to serum ßHCG (IU/L) measurement in all patients undergoing ART procedures.	1 year
Secondary	Comparison of live birth incidence with serum ßHCG confounders	Comparison of live birth incidence according to possible risk factors for serum ßHCG (IU/L) measurements, among patients undergoing ART procedures.	1 year