Predictive Value of Sequential βHCG in IVF Pregnancy

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pregnancy Early

Clinical Trial Details

NCT number	NCT05305027
Study type	Observational
Source	Istituto Clinico Humanitas
Contact
Status	Completed
Phase
Start date	January 1, 2011
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03754621` - Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
Terminated	`NCT04454749` - Endometrial Compaction and Its Influence on Pregnancy Rate in Frozen Embryo Cycle Regimes
Completed	`NCT03743922` - The Effects of Vitamin D2 Supplement During Pregnancy	N/A
Completed	`NCT03957200` - Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound
Terminated	`NCT03954587` - What is the Optimal Cycle Regimen for Frozen- Thawed Embryo Transfer Cycles
Active, not recruiting	`NCT05492981` - Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?	N/A
Completed	`NCT02510209` - Evaluation of the Teen Outreach Program in Hennepin County, Minnesota	N/A
Completed	`NCT03320226` - A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy	N/A
Completed	`NCT04321564` - Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage
Recruiting	`NCT05870878` - Generation R Next - Optimaal Opgroeien	N/A
Completed	`NCT04565873` - Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy
Completed	`NCT04182750` - Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study	N/A
Completed	`NCT04714905` - Better Understanding the Metamorphosis of Pregnancy (BUMP)
Active, not recruiting	`NCT03461835` - Management of Pregnancies of Unknown Location (PUL)	N/A
Recruiting	`NCT04797338` - Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders	Phase 4
Completed	`NCT03513536` - The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.