FERTILITY AND STERILITY
Vol. 53, No. 3, March 1990
Copyright e 1990 The American Fertility Society
Printed on acid·free paper in U.S.A.
A prospective randomized study of pregnancy rates following intrauterine and intracervical insemination using frozen donor sperm* William Byrd, Ph.D.t Karen Bradshaw, M.D. Bruce Carr, M.D.
Clare Edman, M.D. Janelle Odom, M.D.:j: Gary Ackerman, M.D.
Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
Cryopreserved sperm have lowered fertility when compared with fresh sperm in artificial insemination by donor programs. The purpose of this study was to compare pregnancy rates following intrauterine insemination (lUI) and intracervical insemination (ICI) with cryopreserved sperm in a prospective trial using the patient as her own control. A total of 154 patients were randomized into alternating treatment cycles and underwent 238 cycles of lUI and 229 cycles of ICI. The pregnancy rate per treatment cycle was 9. 7% following lUI and 3.9% following ICI. Treatment outcome was influenced by patient age, ovulatory status, and endometriosis. Pregnancy success correlated well with the postthaw survival of sperm and the number of motile cells inseminated. In spite of having normal semen parameters, some donors were found to have markedly reduced sperm fecundity. We conclude that lUI with cryopreserved sperm can be an effective treatment for couples with infertility, genetic indications, or other reasons. Fertil Steril53:521, 1990
Artificial insemination by donor (AID) is a widely used alternative for the treatment of male factor infertility. There have been several reports in the literature that have compared the efficacy of fresh versus cryopreserved sperm with the general finding that cryopreserved sperm are less effective than fresh sperm in AID programs. 1- 3 The decreased fecundity of cryopreserved sperm is due, in part, to structural damage to the sperm caused by the freezing process. These alterations result in decreased post-thaw survival and motility. 4-6 DeReceived September 20, 1989; revised and accepted November 22, 1989. * Presented at the 44th Annual Meeting of the American Fertility Society, Atlanta, Georgia, October 10 to 13, 1988. t Reprint requests: William Byrd, Ph.D., Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235. t Present Address: Department of Obstetrics and Gynecology, University of Texas Health Science Center, Lubbock, Texas.
Vol. 53, No.3, March 1990
creased penetration of frozen-thawed sperm in the sperm penetration assay5 and in cervical mucus 7 is a good indication of this damage. Following recent recommendations, such as those published by The American Fertility Society,8 there has been a shift from fresh to cryopreserved sperm in AID programs in this country. Therefore, different treatment protocols should be considered to enhance the pregnancy rate of patients undergoing artificial insemination by cryopreserved donor sperm. The present study was designed as a prospectiverandomized trial to evaluate pregnancy rates following intrauterine (lUI) and intracervical insemination (ICI) using cryopreserved donor sperm with each patient serving as her own control. We examined several other patient variables in both conception and nonconception cycles to determine if they influenced the success of AID using cryopreserved sperm. Finally, the influence of post-thaw survival, sperm concentration used for insemination, and donor fecundity were examined.
Byrd et al.
Insemination with frozen donor sperm
521
MATERIALS AND METHODS Patient Selection Women who entered into this study had an average age of 32.1 ± 4.9 years and had experienced 4.6 ± 2.8 years of infertility. Ovulatory status was documented by basal body temperature charts and midluteal-phase serum-progesterone levels or endometrial biopsy. Tubal patency was evaluated by a hysterosalpingogram and/or by laparoscopy. Patients with anovulation, oligo-ovulation, or lutealphase dysfunction were treated with clomiphene citrate. Patients were randomized using a randomnumbers table upon entry into the program. They were then inseminated either by lUI or ICI insemination during the first treatment cycle. If pregnancy did not occur that cycle, the alternate method of insemination was used the next cycle. Frozen sperm used during the various treatment cycles were not always from the same ejaculate but were always from the same donor. Cycles were alternated until either pregnancy occurred, six-treatment cycles had elapsed, or the patient dropped from the program. If patients were not pregnant after six-treatment cycles, they were assigned a new donor. Donor Selection Donors were selected from healthy, medical student volunteers who were screened for heritable or sexually transmittable disease. Minimal requirements for an acceptable semen analysis were 60 X 106 sperm/mL with >60% initial motility. Wereport motility in this report as the percent of sperm that are moving. Several ejaculates were cryopreserved from the same donor and then tested for motility post-thaw. If
Vol. 53, No. 3, March 1990
Copyright e 1990 The American Fertility Society
Printed on acid·free paper in U.S.A.
A prospective randomized study of pregnancy rates following intrauterine and intracervical insemination using frozen donor sperm* William Byrd, Ph.D.t Karen Bradshaw, M.D. Bruce Carr, M.D.
Clare Edman, M.D. Janelle Odom, M.D.:j: Gary Ackerman, M.D.
Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
Cryopreserved sperm have lowered fertility when compared with fresh sperm in artificial insemination by donor programs. The purpose of this study was to compare pregnancy rates following intrauterine insemination (lUI) and intracervical insemination (ICI) with cryopreserved sperm in a prospective trial using the patient as her own control. A total of 154 patients were randomized into alternating treatment cycles and underwent 238 cycles of lUI and 229 cycles of ICI. The pregnancy rate per treatment cycle was 9. 7% following lUI and 3.9% following ICI. Treatment outcome was influenced by patient age, ovulatory status, and endometriosis. Pregnancy success correlated well with the postthaw survival of sperm and the number of motile cells inseminated. In spite of having normal semen parameters, some donors were found to have markedly reduced sperm fecundity. We conclude that lUI with cryopreserved sperm can be an effective treatment for couples with infertility, genetic indications, or other reasons. Fertil Steril53:521, 1990
Artificial insemination by donor (AID) is a widely used alternative for the treatment of male factor infertility. There have been several reports in the literature that have compared the efficacy of fresh versus cryopreserved sperm with the general finding that cryopreserved sperm are less effective than fresh sperm in AID programs. 1- 3 The decreased fecundity of cryopreserved sperm is due, in part, to structural damage to the sperm caused by the freezing process. These alterations result in decreased post-thaw survival and motility. 4-6 DeReceived September 20, 1989; revised and accepted November 22, 1989. * Presented at the 44th Annual Meeting of the American Fertility Society, Atlanta, Georgia, October 10 to 13, 1988. t Reprint requests: William Byrd, Ph.D., Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235. t Present Address: Department of Obstetrics and Gynecology, University of Texas Health Science Center, Lubbock, Texas.
Vol. 53, No.3, March 1990
creased penetration of frozen-thawed sperm in the sperm penetration assay5 and in cervical mucus 7 is a good indication of this damage. Following recent recommendations, such as those published by The American Fertility Society,8 there has been a shift from fresh to cryopreserved sperm in AID programs in this country. Therefore, different treatment protocols should be considered to enhance the pregnancy rate of patients undergoing artificial insemination by cryopreserved donor sperm. The present study was designed as a prospectiverandomized trial to evaluate pregnancy rates following intrauterine (lUI) and intracervical insemination (ICI) using cryopreserved donor sperm with each patient serving as her own control. We examined several other patient variables in both conception and nonconception cycles to determine if they influenced the success of AID using cryopreserved sperm. Finally, the influence of post-thaw survival, sperm concentration used for insemination, and donor fecundity were examined.
Byrd et al.
Insemination with frozen donor sperm
521
MATERIALS AND METHODS Patient Selection Women who entered into this study had an average age of 32.1 ± 4.9 years and had experienced 4.6 ± 2.8 years of infertility. Ovulatory status was documented by basal body temperature charts and midluteal-phase serum-progesterone levels or endometrial biopsy. Tubal patency was evaluated by a hysterosalpingogram and/or by laparoscopy. Patients with anovulation, oligo-ovulation, or lutealphase dysfunction were treated with clomiphene citrate. Patients were randomized using a randomnumbers table upon entry into the program. They were then inseminated either by lUI or ICI insemination during the first treatment cycle. If pregnancy did not occur that cycle, the alternate method of insemination was used the next cycle. Frozen sperm used during the various treatment cycles were not always from the same ejaculate but were always from the same donor. Cycles were alternated until either pregnancy occurred, six-treatment cycles had elapsed, or the patient dropped from the program. If patients were not pregnant after six-treatment cycles, they were assigned a new donor. Donor Selection Donors were selected from healthy, medical student volunteers who were screened for heritable or sexually transmittable disease. Minimal requirements for an acceptable semen analysis were 60 X 106 sperm/mL with >60% initial motility. Wereport motility in this report as the percent of sperm that are moving. Several ejaculates were cryopreserved from the same donor and then tested for motility post-thaw. If
