title: The sensitivity and specificity of hyperglycosylated hCG (hhCG) levels to reliably diagnose clinical IVF pregnancies at 6 days following embryo transfer.
abstract: OBJECTIVE
  To determine the sensitivity and specificity of hyperglycosylated hCG (hhCG) measurements for the diagnosis of clinical pregnancies in the IVF setting and how soon post embryo transfer (ET) a pregnancy can be detected using an ultrasensitive (hhCG) assay. To determine if a single, early hhCG measurement can discriminate between biochemical and clinical pregnancies.
  
  
  METHODS
  A 4 center prospective blinded clinical trial was performed with patients undergoing IVF-ET. Patients had blood drawn and submitted for hhCG analysis on the day of ET and at days 4, 6, 8, and 12 thereafter. First morning urines were collected and submitted for hhCG analysis on days 0, 4, 6, 8, 10 and 12.
  
  
  METHODS
  Fertility Centers
  
  
  METHODS
  Clinical pregnancies were defined as an ultrasound study demonstrating a gestational sac and/or heart beat at appropriate gestational ages.
  
  
  RESULTS
  Fifty-six of 58 enrolled patients completed the study. There were 25 clinical and 6 biochemical pregnancies. For blastocyst transfers, a single serum or urine hhCG measurement identified pregnancies (both biochemical and clinical) at 6 days post ET with 100% sensitivity and specificity. There were 6 biochemical pregnancies, all following blastocyst transfers. All of these pregnancies were identified by lower values.
authors.affiliation: Quest Diagnostics Nichols Institute, San Juan Capistrano, CA 92675-2042, USA. charles.m.strom@questdiagnostics.com
authors.forename: Charles M
authors.initials: CM
authors.lastname: Strom
authors.forename: Ruben
authors.initials: R
authors.lastname: Bonilla-Guererro
authors.forename: Ke
authors.initials: K
authors.lastname: Zhang
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Doody
authors.forename: David
authors.initials: D
authors.lastname: Tourgeman
authors.forename: Ruben
authors.initials: R
authors.lastname: Alvero
authors.forename: Marcelle I
authors.initials: MI
authors.lastname: Cedars
authors.forename: Beryl
authors.initials: B
authors.lastname: Crossley
authors.forename: Raj
authors.initials: R
authors.lastname: Pandian
authors.forename: Rajesh
authors.initials: R
authors.lastname: Sharma
authors.forename: Julie
authors.initials: J
authors.lastname: Neidich
authors.forename: Denise
authors.initials: D
authors.lastname: Salazar
mesh_terms: D000328:Adult; D006063:Chorionic Gonadotropin / Q000097:blood*; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D006031:Glycosylation; D006801:Humans; D011247:Pregnancy; D018873:Pregnancy Rate; D011258:Pregnancy Tests / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D006063:Chorionic Gonadotropin; C024889:glycosylated HCG