title: Duration of luteal support (DOLS) with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Luteal support with progesterone is necessary for successful implantation of the embryo following egg collection and embryo transfer in an in-vitro fertilization (IVF) cycle. Progesterone has been used for as little as 2 weeks and for as long as 12 weeks of gestation. The optimal length of treatment is unresolved at present and it remains unclear how long to treat women receiving luteal supplementation.
  
  
  METHODS
  The trial is a prospective, randomized, double-blind, placebo-controlled trial to investigate the effect of the duration of luteal support with progesterone in IVF cycles. Following 2 weeks standard treatment and a positive biochemical pregnancy test, this randomized control trial will allocate women to a supplementary 8 weeks treatment with vaginal progesterone or 8 weeks placebo. Further studies would be required to investigate whether additional supplementation with progesterone is beneficial in early pregnancy.
  
  
  CONCLUSIONS
  Currently at the Hewitt Centre, approximately 32.5% of women have a positive biochemical pregnancy test 2 weeks after embryo transfer. It is this population that is eligible for trial entry and randomization. Once the patient has confirmed a positive urinary pregnancy test they will be invited to join the trial. Once the consent form has been completed by the patient a trial prescription sheet will be sent to pharmacy with a stated collection time. The patient can then be randomized and the drugs dispensed according to pharmacy protocol. A blood sample will then be drawn for measurement of baseline hormone levels (progesterone, estradiol, free beta-human chorionic gonadotrophin, pregnancy-associated plasma protein-A, Activin A, Inhibin A and Inhibin B). The primary outcome measure is the proportion of all randomized women that continue successfully to a viable pregnancy (at least one fetus with fetal heart rate >100 beats/minute) on transabdominal/transvaginal ultrasound at 10 weeks post embryo transfer/12 weeks gestation (that is at the end of 8 weeks supplementary trial treatment).
  
  
  BACKGROUND
  ISRCTN05696887.
authors: Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK. gazvani@hotmail.com
authors: Rafet
authors: R
authors: Gazvani
authors: Richard
authors: R
authors: Russell
authors: Yasmin
authors: Y
authors: Sajjad
authors: Zarko
authors: Z
authors: Alfirevic
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D002985:Clinical Protocols; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D010064:Embryo Implantation / Q000187:drug effects; D004624:Embryo Transfer; D004739:England; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage*; D005307:Fertilization in Vitro; D006801:Humans; D008183:Luteal Phase / Q000187:drug effects*; D054315:Oocyte Retrieval; D010570:Pessaries; D011247:Pregnancy; D018873:Pregnancy Rate; D011258:Pregnancy Tests; D011374:Progesterone / Q000008:administration & dosage*; D011446:Prospective Studies; D027724:Reproductive Techniques, Assisted; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D016216:Ultrasonography, Prenatal
chemical_list: D005300:Fertility Agents, Female; D011374:Progesterone