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Evaluation of a New Silastic Seminal Fluid Collection Device*
FERTILITY AND STERILITY
Copyright
©
Vol. 30, No. 3, September 1978 Printed in U.SA.
1978 The American Fertility Society
EVALUATION OF A NEW SILASTIC SEMINAL FLUID COLLECTION DEVICE*
CY SCHOENFELD, PH.D.t RICHARD D. AMELAR, M.D-* LAWRENCE DUBIN, M.D-* ROBERT G. SKWERER§ Fertility Laboratory, Inc., and Department of Urology, New York University School of Medicine, New York, New York 10016, and Oberlin College, Oberlin, Ohio 44074
A new Silastic seminal fluid collection device has been tested and compared in vitro with glass jars, latex condoms, and the Milex polyethylene sheath. In a series of tests utilizing 50 different semen samples and observing the effects on motility over a period of 4 hours, the Silastic seminal fluid collection device demonstrated sperm survival slightly better than that with glass jars, superior to that with the polyethylene Milex sheath, and far greater survival (by several hours) than with the latex condom. The Silastic collection device was found to be more comfortable and more pleasurable to the patients than was the Milex sheath. The accuracy of seminal volume measurements was also found to be better in the Silastic collection device. Fertil Steril30:319, 1978
The collection of a semen specimen by masturbation or coitus interruptus may be proscribed on religious grounds. 1 Occasionally a patient may be unable to masturbate for personal or psychologic reasons. To circumvent this problem in the past, the use of a polyethylene sheath made by the Milex Corporation of Chicago, Ill., was employed. Patients frequently complained of discomfort and inconvenience in the use of this sheath and occasionally refused to comply with the doctor's requests. Recently, a Silastic seminal fluid collection device was developed by the Dow Corning Corporation of Midland, Mich., on the basis of a concept suggested by Mehan and Chevhal. 2 This device appears to have the advantages of a latex condom with none of its spermicidal qualities.
Silastic is the registered trade name for a dimethylpolysiloxane elastomer which is a silicone compound that has been reported to be nonreactive with living tissues. This paper compares, in vitro, the Silastic seminal fluid collection device with the Milex polyethylene sheath, the latex condom, and the usual glass containers used for the collection of semen specimens by masturbation. We also report on the esthetic qualities of the Silastic device as compared with the Milex sheath, in vivo, as well as the recoverability of semen from these two devices. MATERIALS AND METHODS
Fifty semen specimens obtained by masturbation after a period of abstinence of 3 to 4 days were brought into the laboratory in a glass container within 1 hour of collection. Each had a volume of 2.5 ml or greater. On arrival at the laboratory, 0.5-ml aliquots from each specimen were placed in (1) a Silastic seminal fluid collection device (provided through the courtesy of Dow Corning Corporation, Midland, Mich., (2) a Milex seminal sheath, (3) a latex condom (containing no
Received April 7, 1978; accepted April 28, 1978. *Presented at the Thirty-Fourth Annual Meeting of The American Fertility Society, March 29 to April 1, 1978, New Orleans, La. tFertility Laboratory, Inc., and Department of Urology, New York University School of Medicine. To whom reprint requests should be addressed at Fertility Laboratory, Inc.,137 East 36th Street, New York, N.Y. 10016. :j:Fertility Laboratory, Inc., and Department of Urology, New York University School of Medicine. §Oberlin College.
319
320
September 1978
SCHOENFELD ET AL.
TABLE 1. Mean Percentage of Motile Spermatozoa• Silastic seminal fluid collection device Milex seminal sheath Latex condom Glass container
OHour
1 Hour
2 Hours
3 Hours
4Hours
52.2± 3.1
51.8± 2.0
48.2± 2.1
44.2 ± 1.9
40.2± 2.0
52.2± 3.1 52.2± 3.1 52.2± 3.1
51.0± 1.9 11.2± 1.8 52.0± 2.1
44.0± 2.3 7.2 ± 1.0 50.4± 1.9
38.6± 1.9 0.2± 0.1 44.2± 2.0
32.2 ± 2.1 0 40.2± 2.0
•Values are means ±standard error.
lubricant), and (4) a glass ointment jar. On the remaining portion of the semen specimen, a standard semen analysis was performed. 3 The initial motility examination was considered to be the zero time. The specimen was kept at 25° C and was examined at 1, 2, 3, and 4 hours for the percentage of motile cells as well as the grade of forward progression. For statistical analysis, the specimens were given grades of 1.0, 1.5, etc., instead of 1, 1+, etc., as normally used in the grading of motility. 3 In order to test the recoverability of semen from the Silastic fluid collection device and the Milex sheath, each collection device was weighed prior to distribution to the patient. Each of 50 patients received one of each device to be tested. When the devices were returned to the laboratory after use, a small hole was cut in the bottom of each device and the device was emptied by compressing it from top to bottom between two small wooden rollers. After this, the devices were reweighed and the difference in weight before and after use was used to determine the residual amount of semen retained by the device. The patients participating in the in vivo part of this study were also given a questionnaire comparing the qualities of both devices. Statistical significance between the various groups was determined by the use of Student's t-test. RESULTS
The changes in the percentage of motile spermatozoa demonstrated by the various seminal fluid collection devices tested are shown in Table 1. Mter 1 hour the latex condom demonstrated only 11.2% motile spermatozoa. At 4 hours, both
the Silastic device and the glass container demonstrated a motility of 40.2%, a significantly g:reater amount of motile cells than was demonstrated by the Milex sheath, which demonstrated 32.2% motile cells. There was virtually no difference between the yield of the Silastic device and that of the glass container. The changes in the forward progression of the motile spermatozoa are shown in Table 2. The latex condom demonstrated a rapid decrease in forward progression as early as the 1st hour. The Milex sheath demonstrated a significant decrease in forward progression after 2 hours as compared with the Silastic seminal fluid device or the glass container. There appeared to be a slightly better forward progression with the Silastic device as compared with the glass container, but this difference was found to be statistically insignificant at both 3 hours and 4 hours. Table 3 demonstrates the mean device weights before and after use of both types of sheaths by patients in this part of the study. The Mil ex sheath had a mean difference of 1.001 gm after its use, thus leaving 1.0 ml of semen not recovered. The Silastic device showed a mean difference of 0.326 gm, or only slightly more than 0.3 ml of semen not recovered. Table 4 shows the results of a questionnaire given to 50 patients who participated in the study. Forty of these patients returned the questionnaire, and, at least subjectively, the Silastic seminal fluid device was preferred by the great majority. DISCUSSION
The finding of a higher percentage of motile spermatozoa in the Silastic seminal fluid collec-
TABLE 2. Mean Forward Progression of Motile Spermatozoa• Silastic seminal fluid collection device Milex seminal sheath Latex condom Glass container •Values are means ±standard error.
ODour
1 Hour
2 Hours
3 Hours
4 Hours
2.6± 0.01
2.5± 0.02
2.3± 0.03
2.3 ± 0.03
2.1 ± 0.03
2.6± 0.01 2.6± 0.01 2.6± 0.01
2.3± 0.02 0.9± 0.05 2.5± 0.03
2.0± 0.03 0.3± 0.06 2.3± 0.04
2.0 ± 0.02 0.04± 0.03 2.2 ± 0.04
1.8± 0.03 0 2.0± 0.03
Vol. 30, No.3
EVALUATION OF A NEW SILASTIC SEMINAL FLUID COLLECTION DEVICE
321
TABLE 3. Residual Amount of Seminal Fluid Remaining in Milex Sheaths and Silastic Seminal Fluid Collection Devices Weight Prior to use"
Milex sheath Silastic seminal fluid collection device
After use and removal of semen11
Residual amount of semen
gm
gm
ml
0.412 ± 0.004 3.082 ± 0.003
1.413 ± 0.002 3.408 ± 0.017
1.001 0.326
"Values are means ±standard error.
tion device in vitro, using the same semen specimen, as compared with the Milex sheath is in accord with the clinical observations of Mehan and ChehvaJ.2 The Silastic device compares favorably with the glass container, which has served well for many years. The ability of spermatozoa to maintain both their percentage of motility as well as their forward progression in this Silastic device compared extremely favorably to their survival in a glass container. The latex condom caused a severe loss of motility and forward progression in as little as 1 hour, and a complete loss of motility within the 4-hour testing period. For this reason patients should be advised that a condom should never be used for the collection of a semen specimen. The Silastic device did not retain as much of the seminal fluid as did the TABLE 4. Comparison of Silastic Seminal Fluid Collection Device and the Milex Sheath• Much better
Fit Color Donning ease Removal ease Tactile characteristics Strength Comfort
Slightly better
No difference
Not as good
Very bad
87.5% 10.0% 75.0% 20.0% 92.5% 5.0%
2.5% 5.0% 2.5%
0 0 0
0 0 0
75.0% 12.5%
12.5%
0
0
0
0
0
12.5% 0
0 0
0 0
95.0%
5.0%
75.0% 12.5% 90.0% 10.0%
" Results of questionnaire returned by 40 patients.
Milex sheath. The mean seminal retention by the Silastic device was slightly more than 0.3 ml as compared with 1.0 ml by the Milex sheath, a difference of more than 3-fold. This better recoverability by the Silastic device would allow for more accurate determination of total sperm counts. The Silastic device appears to be far superior to the latex condom, since no immobilization of spermatozoa was found to occur. The patient responses to the questionnaire comparing the Silastic device to the Milex sheath were unequivocal. Not one of the 40 patients responding preferred the Milex sheath, although a very few found that there was little difference between the two devices. It is our feeling that the Silastic seminal fluid collection device both is very acceptable to the patient and allows a reliable and accurate analysis of the semen specimen. This device should also be of further use in the field of infertility, since it could also be applied to the collection of specimens for artificial insemination. REFERENCES 1. Gordon JA, Amelar RD, Dubin L, Tendler M: Infertility practice and Orthodox Jewish law. Fertil Steril 26:480, 1975 2. Mehan DJ, Chehval MJ: A clinical evaluation of a new Silastic seminal fluid collection device. Fertil Steril 28: 689, 1977 3. Amelar RD, Dubin L, Schoenfeld C: Semen analysis. Urology 2:605, 1973
Copyright
©
Vol. 30, No. 3, September 1978 Printed in U.SA.
1978 The American Fertility Society
EVALUATION OF A NEW SILASTIC SEMINAL FLUID COLLECTION DEVICE*
CY SCHOENFELD, PH.D.t RICHARD D. AMELAR, M.D-* LAWRENCE DUBIN, M.D-* ROBERT G. SKWERER§ Fertility Laboratory, Inc., and Department of Urology, New York University School of Medicine, New York, New York 10016, and Oberlin College, Oberlin, Ohio 44074
A new Silastic seminal fluid collection device has been tested and compared in vitro with glass jars, latex condoms, and the Milex polyethylene sheath. In a series of tests utilizing 50 different semen samples and observing the effects on motility over a period of 4 hours, the Silastic seminal fluid collection device demonstrated sperm survival slightly better than that with glass jars, superior to that with the polyethylene Milex sheath, and far greater survival (by several hours) than with the latex condom. The Silastic collection device was found to be more comfortable and more pleasurable to the patients than was the Milex sheath. The accuracy of seminal volume measurements was also found to be better in the Silastic collection device. Fertil Steril30:319, 1978
The collection of a semen specimen by masturbation or coitus interruptus may be proscribed on religious grounds. 1 Occasionally a patient may be unable to masturbate for personal or psychologic reasons. To circumvent this problem in the past, the use of a polyethylene sheath made by the Milex Corporation of Chicago, Ill., was employed. Patients frequently complained of discomfort and inconvenience in the use of this sheath and occasionally refused to comply with the doctor's requests. Recently, a Silastic seminal fluid collection device was developed by the Dow Corning Corporation of Midland, Mich., on the basis of a concept suggested by Mehan and Chevhal. 2 This device appears to have the advantages of a latex condom with none of its spermicidal qualities.
Silastic is the registered trade name for a dimethylpolysiloxane elastomer which is a silicone compound that has been reported to be nonreactive with living tissues. This paper compares, in vitro, the Silastic seminal fluid collection device with the Milex polyethylene sheath, the latex condom, and the usual glass containers used for the collection of semen specimens by masturbation. We also report on the esthetic qualities of the Silastic device as compared with the Milex sheath, in vivo, as well as the recoverability of semen from these two devices. MATERIALS AND METHODS
Fifty semen specimens obtained by masturbation after a period of abstinence of 3 to 4 days were brought into the laboratory in a glass container within 1 hour of collection. Each had a volume of 2.5 ml or greater. On arrival at the laboratory, 0.5-ml aliquots from each specimen were placed in (1) a Silastic seminal fluid collection device (provided through the courtesy of Dow Corning Corporation, Midland, Mich., (2) a Milex seminal sheath, (3) a latex condom (containing no
Received April 7, 1978; accepted April 28, 1978. *Presented at the Thirty-Fourth Annual Meeting of The American Fertility Society, March 29 to April 1, 1978, New Orleans, La. tFertility Laboratory, Inc., and Department of Urology, New York University School of Medicine. To whom reprint requests should be addressed at Fertility Laboratory, Inc.,137 East 36th Street, New York, N.Y. 10016. :j:Fertility Laboratory, Inc., and Department of Urology, New York University School of Medicine. §Oberlin College.
319
320
September 1978
SCHOENFELD ET AL.
TABLE 1. Mean Percentage of Motile Spermatozoa• Silastic seminal fluid collection device Milex seminal sheath Latex condom Glass container
OHour
1 Hour
2 Hours
3 Hours
4Hours
52.2± 3.1
51.8± 2.0
48.2± 2.1
44.2 ± 1.9
40.2± 2.0
52.2± 3.1 52.2± 3.1 52.2± 3.1
51.0± 1.9 11.2± 1.8 52.0± 2.1
44.0± 2.3 7.2 ± 1.0 50.4± 1.9
38.6± 1.9 0.2± 0.1 44.2± 2.0
32.2 ± 2.1 0 40.2± 2.0
•Values are means ±standard error.
lubricant), and (4) a glass ointment jar. On the remaining portion of the semen specimen, a standard semen analysis was performed. 3 The initial motility examination was considered to be the zero time. The specimen was kept at 25° C and was examined at 1, 2, 3, and 4 hours for the percentage of motile cells as well as the grade of forward progression. For statistical analysis, the specimens were given grades of 1.0, 1.5, etc., instead of 1, 1+, etc., as normally used in the grading of motility. 3 In order to test the recoverability of semen from the Silastic fluid collection device and the Milex sheath, each collection device was weighed prior to distribution to the patient. Each of 50 patients received one of each device to be tested. When the devices were returned to the laboratory after use, a small hole was cut in the bottom of each device and the device was emptied by compressing it from top to bottom between two small wooden rollers. After this, the devices were reweighed and the difference in weight before and after use was used to determine the residual amount of semen retained by the device. The patients participating in the in vivo part of this study were also given a questionnaire comparing the qualities of both devices. Statistical significance between the various groups was determined by the use of Student's t-test. RESULTS
The changes in the percentage of motile spermatozoa demonstrated by the various seminal fluid collection devices tested are shown in Table 1. Mter 1 hour the latex condom demonstrated only 11.2% motile spermatozoa. At 4 hours, both
the Silastic device and the glass container demonstrated a motility of 40.2%, a significantly g:reater amount of motile cells than was demonstrated by the Milex sheath, which demonstrated 32.2% motile cells. There was virtually no difference between the yield of the Silastic device and that of the glass container. The changes in the forward progression of the motile spermatozoa are shown in Table 2. The latex condom demonstrated a rapid decrease in forward progression as early as the 1st hour. The Milex sheath demonstrated a significant decrease in forward progression after 2 hours as compared with the Silastic seminal fluid device or the glass container. There appeared to be a slightly better forward progression with the Silastic device as compared with the glass container, but this difference was found to be statistically insignificant at both 3 hours and 4 hours. Table 3 demonstrates the mean device weights before and after use of both types of sheaths by patients in this part of the study. The Mil ex sheath had a mean difference of 1.001 gm after its use, thus leaving 1.0 ml of semen not recovered. The Silastic device showed a mean difference of 0.326 gm, or only slightly more than 0.3 ml of semen not recovered. Table 4 shows the results of a questionnaire given to 50 patients who participated in the study. Forty of these patients returned the questionnaire, and, at least subjectively, the Silastic seminal fluid device was preferred by the great majority. DISCUSSION
The finding of a higher percentage of motile spermatozoa in the Silastic seminal fluid collec-
TABLE 2. Mean Forward Progression of Motile Spermatozoa• Silastic seminal fluid collection device Milex seminal sheath Latex condom Glass container •Values are means ±standard error.
ODour
1 Hour
2 Hours
3 Hours
4 Hours
2.6± 0.01
2.5± 0.02
2.3± 0.03
2.3 ± 0.03
2.1 ± 0.03
2.6± 0.01 2.6± 0.01 2.6± 0.01
2.3± 0.02 0.9± 0.05 2.5± 0.03
2.0± 0.03 0.3± 0.06 2.3± 0.04
2.0 ± 0.02 0.04± 0.03 2.2 ± 0.04
1.8± 0.03 0 2.0± 0.03
Vol. 30, No.3
EVALUATION OF A NEW SILASTIC SEMINAL FLUID COLLECTION DEVICE
321
TABLE 3. Residual Amount of Seminal Fluid Remaining in Milex Sheaths and Silastic Seminal Fluid Collection Devices Weight Prior to use"
Milex sheath Silastic seminal fluid collection device
After use and removal of semen11
Residual amount of semen
gm
gm
ml
0.412 ± 0.004 3.082 ± 0.003
1.413 ± 0.002 3.408 ± 0.017
1.001 0.326
"Values are means ±standard error.
tion device in vitro, using the same semen specimen, as compared with the Milex sheath is in accord with the clinical observations of Mehan and ChehvaJ.2 The Silastic device compares favorably with the glass container, which has served well for many years. The ability of spermatozoa to maintain both their percentage of motility as well as their forward progression in this Silastic device compared extremely favorably to their survival in a glass container. The latex condom caused a severe loss of motility and forward progression in as little as 1 hour, and a complete loss of motility within the 4-hour testing period. For this reason patients should be advised that a condom should never be used for the collection of a semen specimen. The Silastic device did not retain as much of the seminal fluid as did the TABLE 4. Comparison of Silastic Seminal Fluid Collection Device and the Milex Sheath• Much better
Fit Color Donning ease Removal ease Tactile characteristics Strength Comfort
Slightly better
No difference
Not as good
Very bad
87.5% 10.0% 75.0% 20.0% 92.5% 5.0%
2.5% 5.0% 2.5%
0 0 0
0 0 0
75.0% 12.5%
12.5%
0
0
0
0
0
12.5% 0
0 0
0 0
95.0%
5.0%
75.0% 12.5% 90.0% 10.0%
" Results of questionnaire returned by 40 patients.
Milex sheath. The mean seminal retention by the Silastic device was slightly more than 0.3 ml as compared with 1.0 ml by the Milex sheath, a difference of more than 3-fold. This better recoverability by the Silastic device would allow for more accurate determination of total sperm counts. The Silastic device appears to be far superior to the latex condom, since no immobilization of spermatozoa was found to occur. The patient responses to the questionnaire comparing the Silastic device to the Milex sheath were unequivocal. Not one of the 40 patients responding preferred the Milex sheath, although a very few found that there was little difference between the two devices. It is our feeling that the Silastic seminal fluid collection device both is very acceptable to the patient and allows a reliable and accurate analysis of the semen specimen. This device should also be of further use in the field of infertility, since it could also be applied to the collection of specimens for artificial insemination. REFERENCES 1. Gordon JA, Amelar RD, Dubin L, Tendler M: Infertility practice and Orthodox Jewish law. Fertil Steril 26:480, 1975 2. Mehan DJ, Chehval MJ: A clinical evaluation of a new Silastic seminal fluid collection device. Fertil Steril 28: 689, 1977 3. Amelar RD, Dubin L, Schoenfeld C: Semen analysis. Urology 2:605, 1973