title: Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics.
abstract: OBJECTIVE
  To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications.
  
  
  METHODS
  Randomized, prospective clinical trial.
  
  
  METHODS
  Multicenter university-based clinical practices.
  
  
  METHODS
  A total of 900 couples with unexplained infertility.
  
  
  METHODS
  Collection of baseline demographics, blood samples, and ultrasonographic assessments.
  
  
  METHODS
  Demographic, laboratory, imaging, and survey characteristics.
  
  
  RESULTS
  Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners.
  
  
  CONCLUSIONS
  The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment.
  
  
  BACKGROUND
  NCT 01044862.
authors.affiliation: Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, Georgia; Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan. Electronic address: Michael.Diamond@gru.edu.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.affiliation: Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Christos
authors.initials: C
authors.lastname: Coutifaris
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
authors.forename: Ruben
authors.initials: R
authors.lastname: Alvero
authors.affiliation: Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.
authors.forename: Randal D
authors.initials: RD
authors.lastname: Robinson
authors.affiliation: Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.
authors.forename: Peter
authors.initials: P
authors.lastname: Casson
authors.affiliation: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Christman
authors.affiliation: Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
authors.forename: Joel
authors.initials: J
authors.lastname: Ager
authors.affiliation: Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.
authors.forename: Hao
authors.initials: H
authors.lastname: Huang
authors.affiliation: Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
authors.forename: Karl R
authors.initials: KR
authors.lastname: Hansen
authors.affiliation: Stanford University Medical Center, Stanford, California.
authors.forename: Valerie
authors.initials: V
authors.lastname: Baker
authors.affiliation: Carolinas Medical Center, Charlotte, North Carolina.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Usadi
authors.affiliation: New Jersey Medical School - University of Medicine and Dentistry of New Jersey, Rutgers, New Jersey.
authors.forename: Aimee
authors.initials: A
authors.lastname: Seungdamrong
authors.affiliation: University of Alabama Birmingham, Birmingham, Alabama.
authors.forename: G Wright
authors.initials: GW
authors.lastname: Bates
authors.affiliation: Department of Reproductive Endocrinology and Infertility, University of California, San Francisco, California.
authors.forename: R Mitchell
authors.initials: RM
authors.lastname: Rosen
authors.affiliation: Ligand Core Laboratory University of Virginia Center for Research in Reproduction, Charlottesville, Virginia.
authors.forename: Daniel
authors.initials: D
authors.lastname: Haisonleder
authors.affiliation: Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Krawetz
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Kurt
authors.initials: K
authors.lastname: Barnhart
authors.affiliation: Upstate University Hospital, Syracuse, New York.
authors.forename: J C
authors.initials: JC
authors.lastname: Trussell
authors.affiliation: Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.
authors.forename: Yufeng
authors.initials: Y
authors.lastname: Jin
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
authors.forename: Nanette
authors.initials: N
authors.lastname: Santoro
authors.affiliation: Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland.
authors.forename: Esther
authors.initials: E
authors.lastname: Eisenberg
authors.affiliation: Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.
authors.forename: Heping
authors.initials: H
authors.lastname: Zhang
mesh_terms: D000328:Adult; D002996:Clomiphene / Q000627:therapeutic use*; D005260:Female; D005300:Fertility Agents, Female / Q000145:classification / Q000627:therapeutic use*; D006062:Gonadotropins / Q000627:therapeutic use*; D006801:Humans; D007247:Infertility, Female / Q000453:epidemiology* / Q000628:therapy*; D000077289:Letrozole; D008297:Male; D009570:Nitriles / Q000627:therapeutic use*; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D011272:Pregnancy, Multiple / Q000706:statistics & numerical data*; D011788:Quality of Life; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D005300:Fertility Agents, Female; D006062:Gonadotropins; D009570:Nitriles; D014230:Triazoles; D002996:Clomiphene; D000077289:Letrozole
keywords: Unexplained infertility; aromatase inhibitors; clomiphene citrate; gonadotropins; letrozole; multiple gestations