title: A randomized clinical trial to determine optimal infertility treatment in older couples: the Forty and Over Treatment Trial (FORT-T).
abstract: OBJECTIVE
  To determine the optimal infertility therapy for women at the end of their reproductive potential.
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  Academic medical centers and private infertility center in a state with mandated insurance coverage.
  
  
  METHODS
  Couples with ≥ 6 months of unexplained infertility; female partner aged 38-42 years.
  
  
  METHODS
  Randomized to treatment with two cycles of clomiphene citrate (CC) and intrauterine insemination (IUI), follicle stimulating hormone (FSH)/IUI, or immediate IVF, followed by IVF if not pregnant.
  
  
  METHODS
  Proportion with a clinically recognized pregnancy, number of treatment cycles, and time to conception after two treatment cycles and at the end of treatment.
  
  
  RESULTS
  We randomized 154 couples to receive CC/IUI (N = 51), FSH/IUI (N = 52), or immediate IVF (N = 51); 140 (90.9%) couples initiated treatment. The cumulative clinical pregnancy rates per couple after the first two cycles of CC/IUI, FSH/IUI, or immediate IVF were 21.6%, 17.3%, and 49.0%, respectively. After all treatments, 110 (71.4%) of 154 couples had conceived a clinically recognized pregnancy, and 46.1% had delivered at least one live-born baby; 84.2% of all live-born infants resulting from treatment were achieved via IVF. There were 36% fewer treatment cycles in the IVF arm compared with either COH/IUI arm, and the couples conceived a pregnancy leading to a live birth after fewer treatment cycles.
  
  
  CONCLUSIONS
  A randomized controlled trial in older women with unexplained infertility to compare treatment initiated with two cycles of controlled ovarian hyperstimulation/IUI versus immediate IVF demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group.
  
  
  BACKGROUND
  NCT00246506.
authors.affiliation: Department of Obstetrics and Gynecology, Geisel School of Medicine at Dartmouth and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Community and Family Medicine, Geisel School of Medicine at Dartmouth and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. Electronic address: marlene.b.goldman@dartmouth.edu.
authors.forename: Marlene B
authors.initials: MB
authors.lastname: Goldman
authors.affiliation: Boston IVF, Waltham, Massachusetts.
authors.forename: Kim L
authors.initials: KL
authors.lastname: Thornton
authors.affiliation: Boston IVF, Waltham, Massachusetts.
authors.forename: David
authors.initials: D
authors.lastname: Ryley
authors.affiliation: Boston IVF, Waltham, Massachusetts.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Alper
authors.affiliation: Department of Obstetrics and Gynecology, Geisel School of Medicine at Dartmouth and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: June L
authors.initials: JL
authors.lastname: Fung
authors.affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Hornstein
authors.affiliation: Department of Obstetrics and Gynecology, Geisel School of Medicine at Dartmouth and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; American Society for Reproductive Medicine, Birmingham, Alabama.
authors.forename: Richard H
authors.initials: RH
authors.lastname: Reindollar
mesh_terms: D000328:Adult; D000367:Age Factors; D001900:Boston; D002996:Clomiphene / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005298:Fertility; D005300:Fertility Agents, Female / Q000008:administration & dosage; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage; D006801:Humans; D007247:Infertility, Female / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D007248:Infertility, Male / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D007315:Insemination, Artificial; D050498:Live Birth; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011247:Pregnancy; D018873:Pregnancy Rate; D027724:Reproductive Techniques, Assisted; D012307:Risk Factors; D013997:Time Factors; D061685:Time-to-Pregnancy; D016896:Treatment Outcome
chemical_list: D005300:Fertility Agents, Female; D002996:Clomiphene; D005640:Follicle Stimulating Hormone
keywords: Advanced reproductive age; FORT-T Trial; clomiphene citrate; controlled ovarian hyperstimulation; follicle-stimulating hormone; intrauterine insemination (IUI); in vitro fertilization; unexplained infertility