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The efficacy of postoperative hydrotubation: a randomized prospective multicenter clinical trial
FERTILITY AND 8TERnJTy Copyright" 1984 The American Fertility Society
Vol. 42, No.3, September 1984 Printed in U.S.A.
The efficacy of postoperative hydrotubation: a randomized prospective multicenter clinical trial John A. Rock, M.D.* Alvin M. Siegler, M.D.t Marguite Boer Meisel, M.D.:j: Arthur F. Haney, M.D.§ Zev Rosenwaks, M.D.II Francisco Pardo-Vargas, M.D.~ Allyn W. Kimball, Ph.D.** The Johns Hopkins Hospital, Baltimore, Maryland, State University of New York, Downstate Medical Center, Brooklyn, New York, Academisch Ziekenhuis der Uriji Universiteit, Amsterdam, The Netherlands, Duke University Medical Center, Durham, North Carolina, Eastern Virginia Medical School, Norfolk, Virginia, and Ponti/icia Universidad Javeriana, Bogota, Colombia, South America
Term pregnancies following surgery on patients with distal tubal obstruction have been disappointingly few. There has been continuing interest in whether postoperative hydrotubation increases the rate of pregnancy following salpingoneostomy and fimbrioplasty. This hypothesis was tested in a prospective, randomized, multicenter clinical trial. Patients with no infertility factors other than distal fimbrial disease were randomly assigned to either a control group (no hydrotubation, n = 86) or one of two treatment groups (hydrotubation with lactated Ringer's solution, n = 60, or lactated Ringer's solution containing hydrocortisone, n = 60). The statistical evaluation of differences among treatment groups was based on the Cox Proportional Hazards Model, which allows for covariable adjustment and for the inclusion of all patients regardless of the length of follow-up. A significant difference in the live birth rate could not be demonstrated among the groups studied (P = 0.36). The probability of a successful live birth among women treated by hydrotubation with hydrocortisone was about one-half that of the other groups (P = 0.12). Patients with moderate and severe disease had a substantially lower probability of pregnancy than those with mild disease (P = 0.013 and P = 0.0016, respectively). The probability of pregnancy increased somewhat as the number of previous pregnancies increased (P = 0.12). In this clinical trial, a beneficial effect following postoperative hydrotubation could not be demonstrated. Fertil SteriI42:373, 1984
Received February 27, 1984; revised and accepted May 14, 1984. *Reprint requests: John A. Rock, M.D., Department of Obstetrics and Gynecology, The Johns Hopkins Hospital, 600 North Wolfe Street, Baltimore, Maryland 21205. tState University of New York, Downstate Medical Center. :j:Academisch Ziekenhuis der Uriji Universiteit. §Duke University Medical Center. liEastern Virginia Medical School. lIPontificia Universidad Javeriana. **Department of Biostatistics, School of Hygiene and Public Health, The Johns Hopkins Hospital.
Vol. 42, No.3, September 1984
Tubal infection and the resultant anatomic and pathologic alteration of the oviduct is one of the most serious and most common factors influencing infertility. Results oftuboplasty to lyse adhesions and establish tubal patency have been disappointing. Adjuvant therapy was designed to increase chances of pregnancy postoperatively. Despite the lack of demonstrated efficacy, postoperative hydrotubation has received popularity in this country and abroad. 1 This report presents a randomized multicenter clinical trial designed to Rock et aI. Postoperative hydrotubation
373
ascertain the efficacy of postoperative hydrotubation in patients with fimbrial disease who have been surgically treated by fimbrioplasty and salpingoneostomy. MATERIALS AND METHODS
This clinical trial involved five centers, which· contributed 206 patients between January 1, 1978, and December 31, 1981. The organization included a steering committee composed of the principal investigator, co-investigators, and a statistician. The Treatment Effects Monitoring Committee included a biostatistician, a gynecologist, and a bioethicist who periodically reviewed data on pregnancy, side effects, and outcome to make a judgment as to whether the study should be continued unaltered. Each patient received a thorough infertility evaluation in an attempt to search for other factors which might explain her infertility. All patients were less than 36 years of age and were infertile for at least 1 year prior to evaluation. The preoperative evaluation included a hysterosalpingogram, documentation of ovulation, a postcoital test, and a semen analysis. Laparoscopy was performed in > 90% of patients. Patients were considered infertile because of distal tubal disease requiring bilateral salpingoneostomy, fimbrioplasty, or unilateral operation on a residual tube. The surgical procedures utilized in this study were classified after Siegler.2 The extent of disease was carefully documented according to the classification described by Rock et al. 3 All patients received prophylactic antibiotics with the specific agent left to the discretion of the participants. The investigators performed all surgical procedures using standard microsurgical techniques. 4 The surgeons met prior to the trial and during the study to ensure some uniformity in surgical technique. This study was approved by the Joint Committee on Clinical Investigation of each collaborating institution. After appropriate informed consent, a card was drawn from a previous randomized deck in which there were three possible choices. Group 1 consisted of patients who received no hydrotubation. Group 2 consisted of patients who were treated by hydrotubation with 50 ml of lactated Ringer's solution. In group 3, the hydrotubation included 50 ml of lactated Ringer's and 150 mg of hydrocortisone. Hydrotubation treatments were performed on the first postoperative day and con374
Rock et al. Postoperative hydrotubation
tinued every 24 hours for 3 days. One additional treatment was given the day of discharge. Hydrotubation was performed with either a Rubin's cannula attached to a tenaculum on the cervix or a vacuum cervical adaptor. Postoperative hydrotubation was the sole adjunctive therapy given patients following surgery. Preoperative and/or intraoperative adjunctive therapy was not administered. All women were followed for a minimum of 2 years, and half of the cases were followed over 4 years. This follow-up interval was based on lifetable analysis, which demonstrated the expectancy of pregnancy to be < 15% 24 months after treatment. 3 The variable outcome in this study was dichotomous, with a term pregnancy defined as success. Life-table cumulative pregnancy curves have been shown to represent the cumulative probability of a successful pregnancy as a function of follow-up time. Because the curves have not been adjusted for covariables, which might affect the probabilities of a successful pregnancy (i.e., parity and extent of disease), the statistical evaluation of difference among treatment groups was based on the Cox Proportional Hazards Model,5 which allows for covariable adjustments and allows for inclusion of all patients regardless of the length of follow-up. In addition to the treatment variable, covariabIes originally included in the analysis were age, number of previous pregnancies, duration of infertility, and severity of disease. In the first fit to the Cox Proportional Model there were virtually no differences among controls and hydrotubation with lactated Ringer's solution, and so subsequent fits to these two groups were pooled. The effects of age and duration of infertility were found to be negligible, and they were dropped from the analysis. The final analysis included a comparison of the study groups, number of previous pregnancies, and severity of disease. RESULTS
The mean age of patients participating in this study was 28 years (Table 1). The overall gross pregnancy success rate was 21%, with a live birth rate of9.2%. The tubal ectopic rate, based on total pregnancies, was 30% (Table 2). A significant difference in the live birth rate could not be demonstrated among the groups studied (P = 0.36). Because the extent of disease and parity could affect the overall pregnancy success rates within Fertility and Sterility
Table 1. Patient Profile
Age (yrs)
Parity Previous pregnancies Living children Duration of infertility (mos) Interval from surgery to pregnancy (mos)
Mean ± standard deviation
Range
28.8 ± 4.18
19-35
0.75 ± 0.99 0.28 ± 0.68 129 ± 100
0-5 0-4 12-221
12 ± 9
1-36
groups, their frequency within groups was compared. The incidence of mild, moderate, and severe disease was roughly equal among the treatment groups, attesting to proper randomization. When each variable was studied as a separate factor, the probability of a successful pregnancy in patients with moderate to severe disease was substantially lower than in those patients with mild disease (P = 0.013 and P = 0.0016, respectively). The probability of pregnancy increased somewhat as the number of previous pregnancies increased (P = 0.12). The results suggest that postoperative hydro-. tubations did not improve the live birth rate. There were no complications from postoperative hydrotubation and no cases of postoperative tubal infection.
DISCUSSION
Early postoperative hydrotubation was popularized by Grant, l who reported an increased pregnancy rate in an uncontrolled series of 53 consecutive patients. One group of 103 women treated by different techniques of salpingoplasty was not treated with adjuvant therapy. Although 16% of these patients conceived, 3% had tubal pregnancies. In Grant's second group, hydrotubation with hydrocortisone was done every 3 days
postoperatively for 2 weeks, and then less often. Forty-one percent of these women became pregnant within 6 months. A third group of 61 patients who did not achieve pregnancy following salpingoplasty was treated with late hydrotubation. Thirteen percent of this group conceived following the therapy regimen. This is the only study with a series of consecutive patients which revealed an increased pregnancy rate after postoperative hydrotubation, as compared with a control group. Arronet et a1.,6 Grant,! Jessen,7 and Rock et a1. 3 have published reports of series of patients treated with different types and amounts of hydrotub at ion fluids. Due to the wide variety of hydrotubation mixtures and the lack of adherence to a classification of procedures, it is difficult to compare the live birth rate following one regimen with that of another. Furthermore, operative techniques and adjunctive therapies varied, making interpretations of pregnancy successes difficult, if not impossible. This multicenter randomized clinical trial was designed to ascertain the efficacy of postoperative hydrotubation. The choice of lactated Ringer's solution was based on the observation that it does not cause leakage of plasma when placed in the peritoneal cavity. Hydrocortisone was chosen because of its alleged ability to inhibit the fibroblastic proliferation. 2 diZerega and Hodgen8 were able to demonstrate that 32% dextran 70, when placed in the pelvic cavity of the rhesus monkey, decreased adhesion formation by preventing opposition of the fimbrial strands after surgical trauma. Their histopathologic examination of tubal fimbriae after surgical trauma revealed that generalized stromal edema, hemorrhage, and neutrophil infiltration developed within 15 minutes after abrasion. Two days later, epithelial sloughing was evidenced by the absence of columnar and ciliated cells along the periphery, with massive edema,
Table 2. Pregnancy Outcome Following Salpingoneostomy or Fimbrioplasty With or Without Postoperative Hydrotubation
Hydrotubation with 50 ml lactated Ringer's solution alone Hydrotubation with 150 mg hydrocortisone and 50 ml lactated Ringer's solution No hydrotubation Total
Vol. 42, No.3, September 1984
Total patients
Total pregnant
Live birth rate
Spontaneous abortion
60
14 (23%)
6 (10%)
5 (35.7%)
3 (21%)
60
12 (20%)
3 (5%)
3 (25.0%)
6 (50.01%)
86
17 (20%)
10 (11.6%)
3 (17.6%)
4 (23.5%)
206
43 (21%)
19 (9.2%)
11 (25.6%)
13 (30.2%)
Tubal ectopic
Rock et al. Postoperative hydrotubation
375
and arteriolar dilatation and hemorrhage noted in the stroma of the fimbrial tissue. Within 5 days following induced tubal damage, reepithelialization and early clot organization had occurred, with reduction in stromal infiammation and edema. By day 7, restoration of normal tubal epithelium, including ciliated cells, had taken place. These experimental observations suggest that a critical interval of epithelial repair is completed within 3 to 5 days after trauma. Our postoperative hydrotubation schedule provided maximal therapy 3 days after surgical manipulation and an additional treatment upon discharge on day 5 or 6. There is no apparent rationale for continued postoperative hydrotubation after this interval. The extent of disease seems to correlate directly with postoperative subsequent pregnancy success. 3 Careful documentation of the extent of disease in this prospective randomized clinical trial revealed that the probability of pregnancy was lower in women with moderate and severe disease, as compared with patients with mild disease. The distribution of patients with mild disease among the treatment groups was similar (control, 18.6%; lactated Ringer's, 19.6%; and lactated Ringer's + hydrocortisone, 14.5%). Thus, this variable did not bias the results in a particular treatment group. Alternatively, the low live birth rate (9.2%) may be related to the large ilUmher of patients with moderate or severe disease.
378
Rock et aL Postoperative hydrotubation
This multicenter prospective randomized clinical trial underscores the value of cooperation among investigators so that enough patients can be obtained for us to ascertain the efficacy of adjunctive procedures. The results indicate that postoperative hydrotubation had no beneficial effect on the live birth rate after fimbrioplasty or salpingoneostomy. REFERENCES 1. Grant A: Infertility surgery of the oviduct. Fertil Steril
22:496, 1971 2. Siegler AM: Surgical treatments for tuboperitoneal causes of infertility since 1967. Fertil Steril 28:1019, 1977 3. Rock JA, Katayama KP, Martin EJ, Woodruff JD, Jones HW Jr: Factors influencing the success of salpingostomy techniques for distal fimbrial obstruction. Obstet Gynecol 52:591, 1978 4. Jones HW Jr, Rock JA: Reparative and Constructive Surgery of the Female Generative Tract. Baltimore, Williams & Wilkins, 1983, p 77 5. Cox DR: RegreBBion models and life tables. J R Stat Soc (B) 34:187, 1972 6.. Arronet GH, Eduljee SY, O'Brien JR: A nine-year survey of fallopian tube dysfunction in human infertility: diagnosis and therapy. Fertil SteriI20:903, 1969 7. JeBSen H: Forty-five operations for sterility. Obstet Gynecol Surv 27:272, 1972 8. diZerega GS, Hodgen GD: Prevention of postoperative tubal adhesions: comparative study of commonly used agents. Am J Obstet Gynecol 136:173, 1980
Fertility and Sterility
Vol. 42, No.3, September 1984 Printed in U.S.A.
The efficacy of postoperative hydrotubation: a randomized prospective multicenter clinical trial John A. Rock, M.D.* Alvin M. Siegler, M.D.t Marguite Boer Meisel, M.D.:j: Arthur F. Haney, M.D.§ Zev Rosenwaks, M.D.II Francisco Pardo-Vargas, M.D.~ Allyn W. Kimball, Ph.D.** The Johns Hopkins Hospital, Baltimore, Maryland, State University of New York, Downstate Medical Center, Brooklyn, New York, Academisch Ziekenhuis der Uriji Universiteit, Amsterdam, The Netherlands, Duke University Medical Center, Durham, North Carolina, Eastern Virginia Medical School, Norfolk, Virginia, and Ponti/icia Universidad Javeriana, Bogota, Colombia, South America
Term pregnancies following surgery on patients with distal tubal obstruction have been disappointingly few. There has been continuing interest in whether postoperative hydrotubation increases the rate of pregnancy following salpingoneostomy and fimbrioplasty. This hypothesis was tested in a prospective, randomized, multicenter clinical trial. Patients with no infertility factors other than distal fimbrial disease were randomly assigned to either a control group (no hydrotubation, n = 86) or one of two treatment groups (hydrotubation with lactated Ringer's solution, n = 60, or lactated Ringer's solution containing hydrocortisone, n = 60). The statistical evaluation of differences among treatment groups was based on the Cox Proportional Hazards Model, which allows for covariable adjustment and for the inclusion of all patients regardless of the length of follow-up. A significant difference in the live birth rate could not be demonstrated among the groups studied (P = 0.36). The probability of a successful live birth among women treated by hydrotubation with hydrocortisone was about one-half that of the other groups (P = 0.12). Patients with moderate and severe disease had a substantially lower probability of pregnancy than those with mild disease (P = 0.013 and P = 0.0016, respectively). The probability of pregnancy increased somewhat as the number of previous pregnancies increased (P = 0.12). In this clinical trial, a beneficial effect following postoperative hydrotubation could not be demonstrated. Fertil SteriI42:373, 1984
Received February 27, 1984; revised and accepted May 14, 1984. *Reprint requests: John A. Rock, M.D., Department of Obstetrics and Gynecology, The Johns Hopkins Hospital, 600 North Wolfe Street, Baltimore, Maryland 21205. tState University of New York, Downstate Medical Center. :j:Academisch Ziekenhuis der Uriji Universiteit. §Duke University Medical Center. liEastern Virginia Medical School. lIPontificia Universidad Javeriana. **Department of Biostatistics, School of Hygiene and Public Health, The Johns Hopkins Hospital.
Vol. 42, No.3, September 1984
Tubal infection and the resultant anatomic and pathologic alteration of the oviduct is one of the most serious and most common factors influencing infertility. Results oftuboplasty to lyse adhesions and establish tubal patency have been disappointing. Adjuvant therapy was designed to increase chances of pregnancy postoperatively. Despite the lack of demonstrated efficacy, postoperative hydrotubation has received popularity in this country and abroad. 1 This report presents a randomized multicenter clinical trial designed to Rock et aI. Postoperative hydrotubation
373
ascertain the efficacy of postoperative hydrotubation in patients with fimbrial disease who have been surgically treated by fimbrioplasty and salpingoneostomy. MATERIALS AND METHODS
This clinical trial involved five centers, which· contributed 206 patients between January 1, 1978, and December 31, 1981. The organization included a steering committee composed of the principal investigator, co-investigators, and a statistician. The Treatment Effects Monitoring Committee included a biostatistician, a gynecologist, and a bioethicist who periodically reviewed data on pregnancy, side effects, and outcome to make a judgment as to whether the study should be continued unaltered. Each patient received a thorough infertility evaluation in an attempt to search for other factors which might explain her infertility. All patients were less than 36 years of age and were infertile for at least 1 year prior to evaluation. The preoperative evaluation included a hysterosalpingogram, documentation of ovulation, a postcoital test, and a semen analysis. Laparoscopy was performed in > 90% of patients. Patients were considered infertile because of distal tubal disease requiring bilateral salpingoneostomy, fimbrioplasty, or unilateral operation on a residual tube. The surgical procedures utilized in this study were classified after Siegler.2 The extent of disease was carefully documented according to the classification described by Rock et al. 3 All patients received prophylactic antibiotics with the specific agent left to the discretion of the participants. The investigators performed all surgical procedures using standard microsurgical techniques. 4 The surgeons met prior to the trial and during the study to ensure some uniformity in surgical technique. This study was approved by the Joint Committee on Clinical Investigation of each collaborating institution. After appropriate informed consent, a card was drawn from a previous randomized deck in which there were three possible choices. Group 1 consisted of patients who received no hydrotubation. Group 2 consisted of patients who were treated by hydrotubation with 50 ml of lactated Ringer's solution. In group 3, the hydrotubation included 50 ml of lactated Ringer's and 150 mg of hydrocortisone. Hydrotubation treatments were performed on the first postoperative day and con374
Rock et al. Postoperative hydrotubation
tinued every 24 hours for 3 days. One additional treatment was given the day of discharge. Hydrotubation was performed with either a Rubin's cannula attached to a tenaculum on the cervix or a vacuum cervical adaptor. Postoperative hydrotubation was the sole adjunctive therapy given patients following surgery. Preoperative and/or intraoperative adjunctive therapy was not administered. All women were followed for a minimum of 2 years, and half of the cases were followed over 4 years. This follow-up interval was based on lifetable analysis, which demonstrated the expectancy of pregnancy to be < 15% 24 months after treatment. 3 The variable outcome in this study was dichotomous, with a term pregnancy defined as success. Life-table cumulative pregnancy curves have been shown to represent the cumulative probability of a successful pregnancy as a function of follow-up time. Because the curves have not been adjusted for covariables, which might affect the probabilities of a successful pregnancy (i.e., parity and extent of disease), the statistical evaluation of difference among treatment groups was based on the Cox Proportional Hazards Model,5 which allows for covariable adjustments and allows for inclusion of all patients regardless of the length of follow-up. In addition to the treatment variable, covariabIes originally included in the analysis were age, number of previous pregnancies, duration of infertility, and severity of disease. In the first fit to the Cox Proportional Model there were virtually no differences among controls and hydrotubation with lactated Ringer's solution, and so subsequent fits to these two groups were pooled. The effects of age and duration of infertility were found to be negligible, and they were dropped from the analysis. The final analysis included a comparison of the study groups, number of previous pregnancies, and severity of disease. RESULTS
The mean age of patients participating in this study was 28 years (Table 1). The overall gross pregnancy success rate was 21%, with a live birth rate of9.2%. The tubal ectopic rate, based on total pregnancies, was 30% (Table 2). A significant difference in the live birth rate could not be demonstrated among the groups studied (P = 0.36). Because the extent of disease and parity could affect the overall pregnancy success rates within Fertility and Sterility
Table 1. Patient Profile
Age (yrs)
Parity Previous pregnancies Living children Duration of infertility (mos) Interval from surgery to pregnancy (mos)
Mean ± standard deviation
Range
28.8 ± 4.18
19-35
0.75 ± 0.99 0.28 ± 0.68 129 ± 100
0-5 0-4 12-221
12 ± 9
1-36
groups, their frequency within groups was compared. The incidence of mild, moderate, and severe disease was roughly equal among the treatment groups, attesting to proper randomization. When each variable was studied as a separate factor, the probability of a successful pregnancy in patients with moderate to severe disease was substantially lower than in those patients with mild disease (P = 0.013 and P = 0.0016, respectively). The probability of pregnancy increased somewhat as the number of previous pregnancies increased (P = 0.12). The results suggest that postoperative hydro-. tubations did not improve the live birth rate. There were no complications from postoperative hydrotubation and no cases of postoperative tubal infection.
DISCUSSION
Early postoperative hydrotubation was popularized by Grant, l who reported an increased pregnancy rate in an uncontrolled series of 53 consecutive patients. One group of 103 women treated by different techniques of salpingoplasty was not treated with adjuvant therapy. Although 16% of these patients conceived, 3% had tubal pregnancies. In Grant's second group, hydrotubation with hydrocortisone was done every 3 days
postoperatively for 2 weeks, and then less often. Forty-one percent of these women became pregnant within 6 months. A third group of 61 patients who did not achieve pregnancy following salpingoplasty was treated with late hydrotubation. Thirteen percent of this group conceived following the therapy regimen. This is the only study with a series of consecutive patients which revealed an increased pregnancy rate after postoperative hydrotubation, as compared with a control group. Arronet et a1.,6 Grant,! Jessen,7 and Rock et a1. 3 have published reports of series of patients treated with different types and amounts of hydrotub at ion fluids. Due to the wide variety of hydrotubation mixtures and the lack of adherence to a classification of procedures, it is difficult to compare the live birth rate following one regimen with that of another. Furthermore, operative techniques and adjunctive therapies varied, making interpretations of pregnancy successes difficult, if not impossible. This multicenter randomized clinical trial was designed to ascertain the efficacy of postoperative hydrotubation. The choice of lactated Ringer's solution was based on the observation that it does not cause leakage of plasma when placed in the peritoneal cavity. Hydrocortisone was chosen because of its alleged ability to inhibit the fibroblastic proliferation. 2 diZerega and Hodgen8 were able to demonstrate that 32% dextran 70, when placed in the pelvic cavity of the rhesus monkey, decreased adhesion formation by preventing opposition of the fimbrial strands after surgical trauma. Their histopathologic examination of tubal fimbriae after surgical trauma revealed that generalized stromal edema, hemorrhage, and neutrophil infiltration developed within 15 minutes after abrasion. Two days later, epithelial sloughing was evidenced by the absence of columnar and ciliated cells along the periphery, with massive edema,
Table 2. Pregnancy Outcome Following Salpingoneostomy or Fimbrioplasty With or Without Postoperative Hydrotubation
Hydrotubation with 50 ml lactated Ringer's solution alone Hydrotubation with 150 mg hydrocortisone and 50 ml lactated Ringer's solution No hydrotubation Total
Vol. 42, No.3, September 1984
Total patients
Total pregnant
Live birth rate
Spontaneous abortion
60
14 (23%)
6 (10%)
5 (35.7%)
3 (21%)
60
12 (20%)
3 (5%)
3 (25.0%)
6 (50.01%)
86
17 (20%)
10 (11.6%)
3 (17.6%)
4 (23.5%)
206
43 (21%)
19 (9.2%)
11 (25.6%)
13 (30.2%)
Tubal ectopic
Rock et al. Postoperative hydrotubation
375
and arteriolar dilatation and hemorrhage noted in the stroma of the fimbrial tissue. Within 5 days following induced tubal damage, reepithelialization and early clot organization had occurred, with reduction in stromal infiammation and edema. By day 7, restoration of normal tubal epithelium, including ciliated cells, had taken place. These experimental observations suggest that a critical interval of epithelial repair is completed within 3 to 5 days after trauma. Our postoperative hydrotubation schedule provided maximal therapy 3 days after surgical manipulation and an additional treatment upon discharge on day 5 or 6. There is no apparent rationale for continued postoperative hydrotubation after this interval. The extent of disease seems to correlate directly with postoperative subsequent pregnancy success. 3 Careful documentation of the extent of disease in this prospective randomized clinical trial revealed that the probability of pregnancy was lower in women with moderate and severe disease, as compared with patients with mild disease. The distribution of patients with mild disease among the treatment groups was similar (control, 18.6%; lactated Ringer's, 19.6%; and lactated Ringer's + hydrocortisone, 14.5%). Thus, this variable did not bias the results in a particular treatment group. Alternatively, the low live birth rate (9.2%) may be related to the large ilUmher of patients with moderate or severe disease.
378
Rock et aL Postoperative hydrotubation
This multicenter prospective randomized clinical trial underscores the value of cooperation among investigators so that enough patients can be obtained for us to ascertain the efficacy of adjunctive procedures. The results indicate that postoperative hydrotubation had no beneficial effect on the live birth rate after fimbrioplasty or salpingoneostomy. REFERENCES 1. Grant A: Infertility surgery of the oviduct. Fertil Steril
22:496, 1971 2. Siegler AM: Surgical treatments for tuboperitoneal causes of infertility since 1967. Fertil Steril 28:1019, 1977 3. Rock JA, Katayama KP, Martin EJ, Woodruff JD, Jones HW Jr: Factors influencing the success of salpingostomy techniques for distal fimbrial obstruction. Obstet Gynecol 52:591, 1978 4. Jones HW Jr, Rock JA: Reparative and Constructive Surgery of the Female Generative Tract. Baltimore, Williams & Wilkins, 1983, p 77 5. Cox DR: RegreBBion models and life tables. J R Stat Soc (B) 34:187, 1972 6.. Arronet GH, Eduljee SY, O'Brien JR: A nine-year survey of fallopian tube dysfunction in human infertility: diagnosis and therapy. Fertil SteriI20:903, 1969 7. JeBSen H: Forty-five operations for sterility. Obstet Gynecol Surv 27:272, 1972 8. diZerega GS, Hodgen GD: Prevention of postoperative tubal adhesions: comparative study of commonly used agents. Am J Obstet Gynecol 136:173, 1980
Fertility and Sterility