title: Estimating rates of multiple gestation pregnancies: sample size calculation from the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial.
abstract: Infertility afflicts 15% of couples who wish to conceive. Despite intensive evaluation of both male and female partners, the etiology may remain unknown leading to a diagnosis of unexplained infertility. For such couples, treatment often entails ovulation induction (OI) with fertility medications coupled with intrauterine insemination. Complications of this therapy include ovarian hyperstimulation syndrome and creation of multiple gestation pregnancies, which can be complicated by preterm labor and delivery, and the associated neonatal morbidity and expense of care for preterm infants. The Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study is designed to assess whether OI in couples with unexplained infertility with an aromatase inhibitor produces mono-follicular development in most cycles, thereby reducing multiple gestations while maintaining a comparable pregnancy success rate to that achieved by OI with either gonadotropins or clomiphene citrate. These results will provide future guidance of therapy for couples with unexplained infertility, and if comparable pregnancy rates are achieved with a substantial reduction in multiple gestations, the public health benefit will be considerable.
authors.affiliation: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Wayne Sate University, 3800 Woodward Avenue, Suite 320, Detroit, MI 48201, USA. mdiamond@med.wayne.edu
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.forename: Mohamed
authors.initials: M
authors.lastname: Mitwally
authors.forename: Robert
authors.initials: R
authors.lastname: Casper
authors.forename: Joel
authors.initials: J
authors.lastname: Ager
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
authors.forename: Robert
authors.initials: R
authors.lastname: Brzyski
authors.forename: Peter
authors.initials: P
authors.lastname: Casson
authors.forename: Esther
authors.initials: E
authors.lastname: Eisenberg
authors.forename: Heping
authors.initials: H
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D047072:Aromatase Inhibitors / Q000008:administration & dosage; D002996:Clomiphene / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage; D006062:Gonadotropins / Q000008:administration & dosage*; D006801:Humans; D007231:Infant, Newborn; D007246:Infertility / Q000188:drug therapy; D000077289:Letrozole; D008297:Male; D009570:Nitriles / Q000008:administration & dosage*; D010062:Ovulation Induction / Q000379:methods*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011272:Pregnancy, Multiple / Q000706:statistics & numerical data*; D011446:Prospective Studies; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D047072:Aromatase Inhibitors; D005300:Fertility Agents, Female; D006062:Gonadotropins; D009570:Nitriles; D014230:Triazoles; D002996:Clomiphene; D000077289:Letrozole