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Predictive Value of Sequential βHCG in IVF Pregnancy

NCT ID: NCT05305027

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Early

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IVF patients: first serum βHCG

IVF patients who undergo βHCG after fresh or frozen embryo transfer

Prompt diagnois pregnancy outcome

Intervention Type BEHAVIORAL

Interventions

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Prompt diagnois pregnancy outcome

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Michele Tedeschi

MD, Research Administration Manager and Head of Clinical Trial Office Humanitas Clinical and Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Emanuele Levi Setti, MD

Role: STUDY_DIRECTOR

Istituto Clinico Humanitas

References

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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.

Reference Type BACKGROUND
PMID: 16753158 (View on PubMed)

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.

Reference Type RESULT
PMID: 31758302 (View on PubMed)

Other Identifiers

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21012021

Identifier Type: -

Identifier Source: org_study_id