title: Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation.
abstract: OBJECTIVE
  To assess the efficacy and safety of a vaginal progesterone (P(4)) insert (Endometrin) for luteal support for assisted reproductive technology (ART).
  
  
  METHODS
  Multicenter, randomized, open-label (assessor-blinded) phase III clinical trial.
  
  
  METHODS
  Twenty-five U.S. ART centers.
  
  
  METHODS
  A total of 1,211 ART patients randomized to three groups: Endometrin 100 mg twice daily (n = 404), Endometrin 100 mg three times daily (n = 404), and P(4) 90 mg 8% gel daily (n = 403).
  
  
  METHODS
  In vitro fertilization and ET were performed according to site-specific protocols. The day after oocyte retrieval, Endometrin or vaginal P(4) gel was begun for luteal support and continued for up to 10 weeks of pregnancy.
  
  
  METHODS
  Biochemical, clinical, and ongoing pregnancy and live birth rates.
  
  
  RESULTS
  Pregnancy rates were high and similar in all treatment groups, with biochemical rates exceeding 50%, clinical and ongoing rates >or=40%, and live birth rates at 35%-38%. The adverse event profiles were similar across groups.
  
  
  CONCLUSIONS
  Pregnancy rates and live birth rates for Endometrin (twice daily and three times daily) were high and similar to those for P(4) gel. The adverse event profiles for both were similar to that for P(4) gel and primarily due to IVF stimulation and oocyte retrieval. Endometrin was safe and well tolerated.
authors: Center for Assisted Reproduction, Bedford, Texas, USA.
authors: Kevin J
authors: KJ
authors: Doody
authors: Vicki L
authors: VL
authors: Schnell
authors: Russell A
authors: RA
authors: Foulk
authors: Charles E
authors: CE
authors: Miller
authors: Bradford A
authors: BA
authors: Kolb
authors: Emily J
authors: EJ
authors: Blake
authors: Vladimir I
authors: VI
authors: Yankov
mesh_terms: D000293:Adolescent; D000328:Adult; D004338:Drug Combinations; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects; D008183:Luteal Phase / Q000187:drug effects*; D008596:Menotropins / Q000008:administration & dosage* / Q000009:adverse effects; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016037:Single-Blind Method; D016896:Treatment Outcome; D050477:Urofollitropin / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D005300:Fertility Agents, Female; D050477:Urofollitropin; D011374:Progesterone; D008596:Menotropins