title: Intravaginal and intracervical application of seminal plasma in in vitro fertilization or intracytoplasmic sperm injection treatment cycles--a double-blind, placebo-controlled, randomized pilot study.
abstract: OBJECTIVE
  To evaluate whether intravaginal application of seminal plasma at the time of follicle aspiration in IVF or intracytoplasmic sperm injection treatment cycles has the potential to increase pregnancy rate. To calculate the number of patients needed to achieve significance in a multicenter trial.
  
  
  METHODS
  Double-blind, placebo-controlled randomized pilot study.
  
  
  METHODS
  University department of gynecological endocrinology and reproductive medicine.
  
  
  METHODS
  One hundred sixty-eight patients undergoing IVF or intracytoplasmic sperm injection treatment.
  
  
  METHODS
  Cryopreserved seminal plasma from the patient's partner or sodium chloride (placebo) was injected into the cervix and the posterior fornix of the vagina just after follicle aspiration.
  
  
  METHODS
  Clinical-pregnancy rate.
  
  
  RESULTS
  One hundred sixty-eight patients agreed to participate in the study. Participation was limited to one treatment cycle. Thirty-one patients (18%) were excluded from the study, mainly as a result of canceled embryo transfers. Seventy patients received placebo, and 67 received seminal plasma. The clinical-pregnancy rate was 25.7% (18/70) in the placebo group. The clinical-pregnancy rate in the seminal plasma group reached 37.3% (25/67), corresponding to a relative increase of 45%.
  
  
  CONCLUSIONS
  Even though significance was not reached in this pilot study, the data suggest that seminal plasma has the potential to improve pregnancy rate. It is estimated that around 450 patients need to be recruited to reach significance in a multicenter study.
authors.affiliation: Department of Gynecological Endocrinology and Reproductive Medicine, Women's University Hospital, University of Heidelberg, Heidelberg, Germany. michael.von.wolff@med.uni-heidelberg.de
authors.forename: Michael
authors.initials: M
authors.lastname: von Wolff
authors.forename: Sabine
authors.initials: S
authors.lastname: Rösner
authors.forename: Christina
authors.initials: C
authors.lastname: Thöne
authors.forename: Rafael Mota
authors.initials: RM
authors.lastname: Pinheiro
authors.forename: Julia
authors.initials: J
authors.lastname: Jauckus
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.forename: Vanderleyen
authors.initials: V
authors.lastname: Biolchi
authors.forename: Amal
authors.initials: A
authors.lastname: Alia
authors.forename: Thomas
authors.initials: T
authors.lastname: Strowitzki
mesh_terms: D000328:Adult; D002584:Cervix Uteri / Q000502:physiology; D004311:Double-Blind Method; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D007246:Infertility / Q000209:etiology; D007315:Insemination, Artificial / Q000379:methods; D008297:Male; D018579:Patient Selection; D010865:Pilot Projects; D010919:Placebos; D011247:Pregnancy; D011256:Pregnancy Outcome; D018873:Pregnancy Rate; D012661:Semen / Q000502:physiology*; D020554:Sperm Injections, Intracytoplasmic / Q000379:methods*; D013094:Spermatozoa / Q000502:physiology*; D017211:Treatment Failure; D014621:Vagina / Q000502:physiology; D055815:Young Adult
chemical_list: D010919:Placebos