SILCS diaphragm: postcoital testing of a new single-size contraceptive device

Background: This study was conducted to compare the effectiveness of a new, single-size silicone contraceptive diaphragm used with either spermicide 12% nonoxynol-9 (N-9)] or lubricant ill preventing sperm from penetrating midcycle cervical mucus. Study design: A crossover postcoital test (PCT) in healthy, Sexually active women not at risk for pregnancy due to tubal occlusion was conducted, Couples had a baseline PCT without a device to verify normal fertility parameters. Qualified Couples underwent Up to two test Cycles using the SILCS diaphragm with a metal spring. A subgroup Of Couples underwent a third test cycle with the SILCS polymer spring diaphragm used with N-9 gel. Results: Fifteen couples completed a baseline cycle and were randomized to order of study gel. Of these 14 couples completed a baseline cycle and at least one test cycle, 12 couples completed a baseline cycle and two test cycles and S couples completed a third test cycle with file polymer spring prototype. Sperm was detected ill the vaginal pool ill all completed test cycles, The SILCS Metal Spring diaphragms used With N-9 gel reduced the average number of progressively motile sperm per high power field in the cervical mucus from a baseline of 12.5 to 0, while use of this device with lubricant reduced the number to 0.5. The SILCS polymer spring diaphragm used with N-9 performed the same as the metal spring used with N-9 Conclusion: The SILCS diaphragm used with N-9 gel performed well. It is likely that the SILCS diaphragm will give acceptable results in a contraceptive effectiveness study but that adjunctive use of a chemical barrier such as N-9 gel will be necessary for it to be most effective. (C) 2008 Elsevier Inc. All rights reserved.