Predictive Value of Sequential βHCG in IVF Pregnancy

NCT05305027 | Completed

• 1 other identifier: 21012021
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy Early

Outcome Measures

Primary Outcomes (1)

• Live birth incidence per serum βHCG value

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

  1 year

Secondary Outcomes (1)

• Comparison of live birth incidence with serum βHCG confounders

  1 year

Study Arms (1)

IVF patients: first serum βHCG

IVF patients who undergo βHCG after fresh or frozen embryo transfer

Behavioral: Prompt diagnois pregnancy outcome

Interventions

Prompt diagnois pregnancy outcome BEHAVIORAL

IVF patients: first serum βHCG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include retrospectively all patients that underwent IVF cycles (including fresh and thawed embryo transfers) between January 2011 and December 2020 at a Third level University-affiliated center, Humanitas Fertility Center in (Rozzano, MI). The internal database (Art-it) will be used to retrieve data on age, body mass index (BMI), baseline sex hormone levels, main causes of infertility, endometrial thickness, details of stimulation protocols, date of insemination, date of embryo transfer, number of embryos transferred, date of βHCG examination, serum concentrations of βHCG, fertilization results, pregnancy types (EP, biochemical pregnancy, intrauterine)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Related 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. doi: 10.1016/j.fertnstert.2005.12.056. Epub 2006 Jun 6.

  PMID: 16753158 BACKGROUND

• 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.

  PMID: 31758302 RESULT

Study Officials

• Paolo Emanuele Levi Setti, MD

  Istituto Clinico Humanitas

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research Administration Manager and Head of Clinical Trial Office Humanitas Clinical and Research Center

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 31, 2022
• Study Start: January 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share