title: Intercoat (Oxiplex/AP gel) for preventing intrauterine adhesions after operative hysteroscopy for suspected retained products of conception: double-blind, prospective, randomized pilot study.
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of Oxiplex/AP gel (Intercoat) in reducing intrauterine adhesion formation after hysteroscopic treatment because of retained products of conception (RPOC).
  
  
  METHODS
  Prospective double-blind, randomized, controlled pilot study (Canadian Task Force classification I).
  
  
  METHODS
  Tertiary medical center.
  
  
  METHODS
  All women who underwent hysteroscopic treatment because of RPOC at our institution between September 2009 and June 2012 were invited to participate. After operative hysteroscopy, participants were randomized to either have their uterine cavity filled with Oxiplex/AP gel (study group, n = 26) or not (control group, n = 26).
  
  
  METHODS
  Diagnostic office hysteroscopy to assess for adhesion formation was performed after 6 to 8 weeks. Findings were graded according to the American Fertility Society classification. Rates of subsequent pregnancy in the 2 groups were assessed.
  
  
  RESULTS
  Intraoperative complication rates were similar between the 2 groups. There were no postoperative complications after Oxiplex/AP gel application. Moderate to severe adhesions developed in 1 woman (4%) in the study group and 3 (14%) in the control group (p = .80). During follow-up of 20 months (range, 2-33 months), 7 women (27%) in the treatment group conceived, compared with 3 (14%) in the control group (p = .50).
  
  
  CONCLUSIONS
  Intrauterine application of Oxiplex/AP gel after hysteroscopic removal of RPOC is safe. In this small sample, the difference in the rate of intrauterine adhesions was not statistically significant. A larger study would enable further establishment of the safety and efficacy of use of this gel.
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: Noga_fuchs@yahoo.com.
authors: Noga
authors: N
authors: Fuchs
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
authors: Noam
authors: N
authors: Smorgick
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
authors: Ido
authors: I
authors: Ben Ami
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
authors: Zvi
authors: Z
authors: Vaknin
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
authors: Yoseph
authors: Y
authors: Tovbin
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
authors: Reuvit
authors: R
authors: Halperin
authors: Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
authors: Moty
authors: M
authors: Pansky
mesh_terms: D000328:Adult; D002482:Cellulose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005333:Fetus / Q000601:surgery*; D006801:Humans; D015907:Hysteroscopy / Q000009:adverse effects*; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011247:Pregnancy; D011446:Prospective Studies; D000267:Tissue Adhesions / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D014591:Uterine Diseases / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*
chemical_list: C406630:Oxiplex; D011092:Polyethylene Glycols; D002482:Cellulose
keywords: Asherman syndrome; Hysteroscopy; Intercoat (Oxiplex/AP gel); Intrauterine adhesions; Retained products of conception