title: Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons.
abstract: OBJECTIVE
  Our long-term goal is to develop a nonsurgical method of fallopian tubal occlusion for the purpose of permanent contraception. We have previously demonstrated that transcervical administration of 5% polidocanol foam (PF) can create tubal occlusion in macaques but that multiple treatments are required. In this study, we assessed the efficacy of various regimens of PF with and without depomedroxyprogesterone acetate (DMPA) (to control ovarian cycle phase) in the baboon.
  
  
  METHODS
  Adult cycling female baboons were evaluated for tubal patency by hysterosalpingography and then received a transcervical infusion of PF with (+) or without (-) an intramuscular injection of DMPA (3.5 mg/kg). Two concentrations of PF were compared: 1% [(+) DMPA, n=5; (-) DMPA, n=3] and 5% [(+) DMPA, n=4; (-) DMPA, n=3]. Controls received (+) DMPA (n=2) or (-) DMPA, (n=3) only. The reproductive tracts were removed 1-3 months after treatment for examination.
  
  
  RESULTS
  No fallopian tubal occlusion was observed in negative controls (±DMPA). Histologic complete tubal occlusion was observed in 3/8 of females treated with 1% PF and in 6/7 treated with 5% PF. Histologic evaluation suggested that 1% PF is associated with prolonged chronic inflammation (more than 2-3 months), while 5% treatment eliminates the epithelial lining, at least focally, and resolves into complete occlusion within 1-2 months. This pattern of complete occlusion was seen in all 4 females that received 5% PF (+DMPA) and in 2/3 that received 5% PF (-DMPA).
  
  
  CONCLUSIONS
  In a baboon model of transcervical permanent contraception, a single treatment with 5% PF resulted in complete tubal occlusion more reliably (85%) than 1% PF (38%). Cotreatment with DMPA may improve treatment results with 5% PF but requires additional study.
  
  
  CONCLUSIONS
  A finding that a single transcervical treatment with 5% PF can occlude the fallopian tubes of baboon supports further study of this approach as a novel strategy for permanent contraception for women.
authors.affiliation: Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR 97239, USA; Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR 97006, USA. Electronic address: jensenje@ohsu.edu.
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Jensen
authors.affiliation: Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR 97006, USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Hanna
authors.affiliation: Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR 97006, USA.
authors.forename: Shan
authors.initials: S
authors.lastname: Yao
authors.affiliation: Southwest National Primate Research Center, San Antonio, TX 78227, USA.
authors.forename: Cassondra
authors.initials: C
authors.lastname: Bauer
authors.affiliation: Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR 97239, USA; Department of Pathology, Oregon Health & Science University, Portland, OR 97239, USA.
authors.forename: Terry K
authors.initials: TK
authors.lastname: Morgan
authors.affiliation: Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR 97239, USA; Division of Reproductive and Developmental Sciences, Oregon National Primate Research Center, Beaverton, OR 97006, USA.
authors.forename: Ov D
authors.initials: OD
authors.lastname: Slayden
mesh_terms: D000282:Administration, Intravaginal; D000818:Animals; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004357:Drug Synergism; D004847:Epithelial Cells / Q000166:cytology / Q000187:drug effects / Q000276:immunology / Q000473:pathology; D005187:Fallopian Tubes / Q000166:cytology / Q000187:drug effects* / Q000276:immunology / Q000473:pathology; D005260:Female; D007047:Hysterosalpingography / Q000187:drug effects; D007273:Injections, Intramuscular; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D008597:Menstrual Cycle / Q000187:drug effects; D048530:Papio anubis; D048529:Papio hamadryas; D010865:Pilot Projects; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D012488:Salpingitis / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000276:immunology / Q000473:pathology; D012597:Sclerosing Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D013246:Sterilization, Tubal / Q000009:adverse effects / Q000379:methods*; D014014:Tissue Adhesives / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology
chemical_list: D003271:Contraceptive Agents, Female; D012597:Sclerosing Solutions; D014014:Tissue Adhesives; D014622:Vaginal Creams, Foams, and Jellies; D000077423:Polidocanol; D011092:Polyethylene Glycols; D017258:Medroxyprogesterone Acetate
keywords: Baboon; Female; Nonsurgical sterilization; Permanent contraception; Polidocanol