Anne Z Steiner1, Michael P Diamond2, Richard S Legro3, William D Schlaff4, Kurt T Barnhart5, Peter R Casson6, Gregory M Christman7, Ruben Alvero4, Karl R Hansen8, William M Geisler9, Tracey Thomas10, Nanette Santoro4, Heping Zhang10, Esther Eisenberg11. 1. Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina. Electronic address: asteiner@med.unc.edu. 2. Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan; Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia. 3. Department of Obstetrics and Gynecology, Penn State University, Hershey, Pennsylvania. 4. Department of Obstetrics and Gynecology, University of Colorado, Aurora, Colorado. 5. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. 6. Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont. 7. Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan. 8. Department of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City, Oklahoma. 9. Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama. 10. Department of Biostatistics, Yale University, New Haven, Connecticut. 11. Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Abstract
OBJECTIVE: To determine if Chlamydia trachomatis (C. trachomatis) seropositivity, as detected by the C. trachomatis elementary body (EB)-based enzyme-linked immunosorbent assay [EB ELISA] predicts pregnancy and pregnancy outcome among infertile women with documented tubal patency. DESIGN: Cohort study. SETTING: Outpatient clinics. PATIENT(S): In all, 1,250 infertile women with documented tubal patency enrolled in 1 of 2 randomized controlled trials: Pregnancy in Polycystic Ovary Syndrome II; and the Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. INTERVENTION(S): Sera were analyzed for anti-C. trachomatis immunoglobulin G (IgG)1 and IgG3 antibodies, using a research C. trachomatis EB ELISA. The optical density (OD)405 readings of ≥ 0.35 and ≥ 0.1 were considered positive for IgG1 and IgG3, respectively. MAIN OUTCOME MEASURE(S): Primary outcomes included pregnancy, live birth, and ectopic pregnancy. Log-linear regression was used to determine the relative risk after adjusting for age, race, treatment medication, smoking status, and current alcohol use. RESULT(S): A total of 243 (19%) women were seropositive for anti-C. trachomatis IgG3. They tended to be nonwhite and smokers. Anti-C. trachomatisIgG3 seropositive women were significantly less likely to conceive (risk ratio [RR] 0.65, 95% confidence interval [CI] 0.52-0.83) or to have a live birth (RR 0.59, 95% CI 0.43-0.80); these associations were weakened after adjusting for number of hysterosalpingography-documented patent tubes (RR 0.73, 95% CI 0.56-0.97) and (RR 0.73, 95% CI 0.50-1.04), respectively. Anti-C. trachomatisIgG3 seropositive women who conceived had a ×2.7 risk (95% CI 1.40-5.34) of ectopic pregnancy. CONCLUSION(S): Even in the presence of tubal patency, anti-C. trachomatis IgG3 seropositivity is associated with a lower likelihood of pregnancy. Anti-C. trachomatisIgG3 seropositive women have as high as 3 times the risk of ectopic pregnancy. CLINICAL TRIAL REGISTRATION NUMBER: PPCOSII: NCT00719186 and AMIGOS: NCT01044862.
RCT Entities:
OBJECTIVE: To determine if Chlamydia trachomatis (C. trachomatis) seropositivity, as detected by the C. trachomatis elementary body (EB)-based enzyme-linked immunosorbent assay [EB ELISA] predicts pregnancy and pregnancy outcome among infertile women with documented tubal patency. DESIGN: Cohort study. SETTING:Outpatient clinics. PATIENT(S): In all, 1,250 infertile women with documented tubal patency enrolled in 1 of 2 randomized controlled trials: Pregnancy in Polycystic Ovary Syndrome II; and the Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. INTERVENTION(S): Sera were analyzed for anti-C. trachomatis immunoglobulin G (IgG)1 and IgG3 antibodies, using a research C. trachomatis EB ELISA. The optical density (OD)405 readings of ≥ 0.35 and ≥ 0.1 were considered positive for IgG1 and IgG3, respectively. MAIN OUTCOME MEASURE(S): Primary outcomes included pregnancy, live birth, and ectopic pregnancy. Log-linear regression was used to determine the relative risk after adjusting for age, race, treatment medication, smoking status, and current alcohol use. RESULT(S): A total of 243 (19%) women were seropositive for anti-C. trachomatisIgG3. They tended to be nonwhite and smokers. Anti-C. trachomatisIgG3 seropositive women were significantly less likely to conceive (risk ratio [RR] 0.65, 95% confidence interval [CI] 0.52-0.83) or to have a live birth (RR 0.59, 95% CI 0.43-0.80); these associations were weakened after adjusting for number of hysterosalpingography-documented patent tubes (RR 0.73, 95% CI 0.56-0.97) and (RR 0.73, 95% CI 0.50-1.04), respectively. Anti-C. trachomatisIgG3 seropositive women who conceived had a ×2.7 risk (95% CI 1.40-5.34) of ectopic pregnancy. CONCLUSION(S): Even in the presence of tubal patency, anti-C. trachomatisIgG3 seropositivity is associated with a lower likelihood of pregnancy. Anti-C. trachomatisIgG3 seropositive women have as high as 3 times the risk of ectopic pregnancy. CLINICAL TRIAL REGISTRATION NUMBER: PPCOSII: NCT00719186 and AMIGOS: NCT01044862.
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