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 [2% nonoxynol-9 (N-9)] or lubricant in preventing sperm from penetrating midcycle cervical mucus.


METHODS
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 8 couples completed a third test cycle with the polymer spring prototype. Sperm was detected in the vaginal pool in 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.


CONCLUSIONS
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.
Schwartz
Jill L
JL
CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA. jschwartz@conrad.org
Ballagh
Susan A
SA
Creinin
Mitchell D
MD
Rountree
Robert W
RW
Kilbourne-Brook
Maggie
M
Mauck
Christine K
CK
Callahan
Marianne M
MM
D000328:Adult; D002582:Cervix Mucus; D003274:Contraceptive Devices, Female; D018592:Cross-Over Studies; D004867:Equipment Design; D005260:Female; D006801:Humans; D054327:Lubricants / Q000627:therapeutic use; D008297:Male; D017137:Nonoxynol / Q000627:therapeutic use*; D013081:Sperm Motility; D013089:Spermatocidal Agents / Q000627:therapeutic use*; D016896:Treatment Outcome
D054327:Lubricants; D013089:Spermatocidal Agents; D017137:Nonoxynol