Intratubal pressure before and after transcervical catheterization of the fallopian tubes.

OBJECTIVE: To assess the intratubal pressure (ITP) and patency status of the fallopian tubes before and after transcervical catheterization of the fallopian tubes (TCFT). DESIGN: Prospective procedural assessment. SETTING: Pope Paul VI Institute for the Study of Human Reproduction. PATIENT(S): Two hundred thirty-four women with either primary or secondary infertility. INTERVENTION(S): Patients underwent selective hysterosalpingography and, in some cases, TCFT with measurement of the ITP before and after the procedure. MAIN OUTCOME MEASURE(S): The ITP before and after TCFT. RESULT(S): The mean (+/-SD) ITP in freely patent tubes was 0.53 +/- 0.06 atm, that in partially obstructed tubes was 1.23 +/- 0.52 atm, and that in completely obstructed tubes was 2.79 +/- 1.40 atm. After TCFT, the mean (+/-SD) ITP in partially obstructed tubes decreased to 0.64 +/- 0.31 atm and that in completely obstructed tubes decreased to 1.86 +/- 1.35 atm. The ITP was normalized in 76% of partially obstructed tubes and in 29.5% of completely obstructed tubes. In all cases of complete obstruction in which surgical correction was attempted, organic pathology was identified. CONCLUSION(S): The procedure described is a safe and easy means of obtaining reliable and significant information on the status of the proximal fallopian tube.

Creighton Model NaProEducation Technology for avoiding pregnancy. Use effectiveness.

OBJECTIVE: To evaluate the use effectiveness of Creighton Model (CrM) NaProEducation Technology for avoiding pregnancy. STUDY DESIGN: CrM is a medical model of natural procreation education that is a fully standardized modification of the Billings ovulation method. This system has been used as a means to avoid pregnancy and has been prospectively evaluated in five use effectiveness studies. A prospective life-table analysis of the five studies (meta-analysis) was undertaken, yielding both net and gross rates. Discontinuation rates were also calculated. These studies were conducted at CrM centers in Omaha, St. Louis, Wichita, Houston, and Milwaukee. RESULTS: A total of 1,876 couples used CrM NET for a total of 17,130.0 couple months of use. The method and use effectiveness rates for avoiding pregnancy were 99.5 and 96.8 at the 12th ordinal month and 99.5 and 96.4 at the 18th ordinal month, respectively. The discontinuation rate was 11.3% at the 12th ordinal month and 12.1% at the 18th ordinal month. CONCLUSION: CrM is highly effective as a means of avoiding pregnancy in both its method and use effectiveness. The method effectiveness has remained stable over the years of the studies, but the use effectiveness for avoiding pregnancy appears to have improved over the study period.

Cumulative pregnancy rates in patients with apparently normal fertility and fertility-focused intercourse.

Fifty consecutive clients achieved pregnancy using a standardization modification of the Billings ovulation method (the Creighton Model Natural Family Planning System). Of 50 clients followed, 38 (76%) achieved pregnancy in the first cycle of fertility-focused intercourse, 45 of 50 (90%) achieved pregnancy by the third cycle and 49 of 50 achieved pregnancy by the sixth cycle (98%).

PIP: The effectiveness of the standardized modification of the Billings ovulation method of natural family planning in fertility focused intercourse was evaluated in a study over 12 months of 50 clients aged 22-38 years. 27 had prior pregnancy/s. All clients had normal fertility. The results indicated a higher probability of conception when the couple was aware of their peak fertile time than previously expected. No clients became pregnant when intercourse was confined to the infertile period. Within 1 cycle, 76.0% became pregnant. By the 3rd cycle, 90.0% became pregnant. By the 6th cycle, 98% (49 out of 50) achieved pregnancy. 71.4% of those with a prior pregnancy conceived after the 1st cycle. 80.9% of nulligravida women achieved pregnancy after 1 cycle, 89.3% of multiparous women became pregnant after the 4th cycle, and 100% of the nulligravida women became pregnant after the 4th cycle. The method entailed learning about the presence or absence of cervical mucus discharge around the time of ovulation. The beginning of the mucus cycle began with a sticky (a quarter of an inch), cloudy or tacky discharge until the last day when the mucus became clear and stretchy or lubricative. The last mucus was considered the peak day. Clients recorded all acts of intercourse and were assessed at follow-up visits every 2 weeks in the 1st 2 months, and then at 3, 6, 9, and 12 months. The fertile period was defined as the 1st day of mucus discharge through 3 full days past the peak day. Ovulation is considered possible +or- 2 days of the peak day for 95.4% of cycles. Studies of random acts of intercourse show less efficient conception rates. A study by Barrett and Marshall found, by using the Vollman basal body temperature method, that daily intercourse around the period of alleged fertility increased the possibility of conception from 24% to 31% for every 3-4 days to 68% for daily. The WHO fertility figure for the ovulation method in a multicentered trial is 66.7%.

A simple, safe technique for placement of the veress needle and trocar in laparoscopy.

A simple technique of placing two Kocher clamps on the anterior rectus fascia for the elevation of the anterior abdominal wall during the insertion of the veress needle and the laparoscopic trocar is described in 243 consecutive patients. There were no failed insufflations during this study and no cases of preperitoneal emphysema. The technique is simple to use and adds safety to a basically blind procedure.

Assessment of the empty follicle syndrome by transvaginal sonography.

The empty follicle syndrome was assessed using transvaginal ultrasonography in a group of 152 consecutive women with unmedicated menstrual cycles being studied because of primary or secondary infertility or repetitive miscarriage. The overall frequency of the empty follicle syndrome was found to be 43.4%. The frequency increased with age but was independent of gravidity. The empty follicle syndrome may be a significant etiologic factor in infertility or other reproductive abnormalities, and transvaginal ultrasound represents a good, non-invasive means of evaluating it.

Safety of intraperitoneal 32% dextran 70 as an antiadhesion adjuvant.

The records of 139 consecutive patients who underwent major gynecologic abdominal surgery in which 32% dextran 70 was used as an antiadhesion adjuvant were carefully reviewed for the presence or absence of dextran-related complications. Eleven patients (8.0%) were thought to have dextran-related complications, including postoperative ileus (2.9%), pleural effusion (2.2%), allergic reactions (1.4%), wound infection (1.4%) and labial swelling (0.7%). The mean amount of dextran used was 183 mL. The study indicated that dextran can be used in moderate amounts when instilled intraperitoneally and has an acceptably low rate of complications. Since dextran is used often in spite of scanty evidence of its effectiveness as an antiadhesion adjuvant, understanding its safety and potential complications is especially important.

Sonographic definition of the empty follicle syndrome.

The sonographic definition of the empty follicle syndrome is presented in a group of 89 consecutive, unmedicated menstrual cycles in women with primary or secondary infertility. The incidence of the empty follicle syndrome was found to be 50%. The incidence increased with age and was independent of gravidity or the type of follicular rupture (or lack of rupture). These data suggest that the empty follicle syndrome may represent a significant etiologic factor in infertility or other reproductive abnormalities.

Evidence for the involvement of beta-endorphin in the human menstrual cycle.

The possibility that beta-endorphin, an endogenous opiate, is involved in the regulation of the menstrual cycle was examined. Daily serum beta-endorphin levels, in conjunction with luteinizing hormone, progesterone, and 17 beta-estradiol were measured during 26 hormonally normal menstrual cycles. Twenty-one cycles showed a preovulatory peak and postovulatory trough of beta-endorphin, 2 cycles had a postovulatory peak, and 3 had a postovulatory peak with sustained elevation. The raw data were standardized by conversion to "Z-scores," and the composite values were computed for each of the three classes described above. Significance within these three classes was assessed using a one-way analysis of variance with an F-ratio at 95% confidence limits. The composite plot of the 26 cycles showed a statistically significant preovulatory peak occurring 2 days prior to the luteinizing hormone surge and a postovulatory trough of beta-endorphin 5 days later. These results suggest that beta-endorphins play a significant role in the neurochemical mechanisms of gonadotropin release.

Natural family planning IV. The identification of postovulatory infertility.

The estimated time of ovulation (ETO) was correlated with the day of defined postovulatory infertility in 66 hormonally normal menstrual cycles from 24 subjects for each of 15 different natural family planning methodologies. Inherent weaknesses were identified in methods based upon calendar calculations or basal body temperature only. These weaknesses could be removed for the basal body temperature-only methods if symptoms, especially the peak mucus symptom, were added to the temperature records. However, the peak mucus symptom alone had the greatest precision of all methods studied. No advantage could be identified in combining the basal body temperature with the peak symptom.

Natural family planning III. Intermenstrual symptoms and estimated time of ovulation.

Several periovulatory symptoms sometimes used in natural family planning are correlated with the estimated time of ovulation in 23 subjects and 64 hormonally normal menstrual cycles. The data suggest that intermenstrual pain may not be due to 1 specific cause but rather to several related factors. As a symptom of ovulation, intermenstrual pain was more specific than lower backache, abdominal bloating, and intermenstrual bleeding nonetheless, intermenstrual pain has a broad periovulatory association. The most reproducible and predictable sign of this series appeared to be the postovulatory occurrence of breast tenderness.

NFP programs provide consumer choice, benefit hospital.

Now that principles of NFP have been established specific programs are necessary to disperse information and to teach techniques. The hospital-based NFP program offers the community a needed service and benefits the hospital.

Two methods of natural family planning.

PIP: I read with interest the recent article by Wade and associates, "A randomized prospective study of the use-effectiveness of 2 methods of natural family planning: an interim report" (134: 628, 1979). In reference to the study of the ovulation method, the authors noted that abstinence begins on the 1st day of mucus secretion and continues until the evening of the 4th day beyond the peak or maximal mucus secretion. In the ovulation method, the peak symptom is not the same as maximal mucus secretion as was indicated in the paper. The peak symptom is defined as the last day of the mucus discharge that is clear and/or stretchy and/or lubricative. In the definition of peak symptom, the amount of mucus discharge is not specifically important and may often be misleading. I had the opportunity to do a site visit at this study at the request of the National Institutes of Health while the study was in progress. I analyzed several pregnancies which occurred in users of this ovulation method. Some of the pregnancies occurred as the result of poor teaching of the concept of peak symptom. In the ovulation method, proper understanding and teaching of that concept are essential to the measurement of its effectiveness. Noticeably missing from this interim report was any discussion of the quality control procedures which were utilized to guarantee a high-quality educational service to the people entered into the study. While the authors claim that the methods were taught by professional teachers, these teachers were actually women who had previously used the method and/or had formalized training in teaching the method. Simple use of either of the methods certainly does not qualify an individual to teach natural family planning. For those with formalized teaching, such training should have been outlined since judgment on the effectiveness of the teaching cannot be made; such a judgment is essential to the proper analysis of results. Finally, while the study claims to be a use-effectiveness study, it is rather a modified version of extended use-effectiveness. No objective definition of "user failure" is provided. One cannot ascertain how many pregnancies were related to poor teaching, nor can one tell how many occurred as the result of the couples' last minute exercise of their freedom to use their fertility. The use-effectiveness of the 2 methods under study as a means to achieve a pregnancy have been ignored. In doing so, the investigators have ignored use-effectiveness reality.^ieng

Natural family planning. II. Basal body temperature and estimated time of ovulation.

Four points on the basal body temperatures (BBT) curve have been correlated with the estimated time of ovulation (ETO), as determined by indirect hormonal parameters, in 74 menstrual cycles from 24 subjects. Only 10 of 66 hormonally normal cycles exhibited a BBT dip (D), and the ETO ranged from D - 2 through D + 3. In 63 of 66 hormonally normal cycles, a BBT nadir (N), first day of BBT rise (F), and BBT coverline endpoint (C) were identified. In these 63 cycles, the ETO ranged from N - 5 through N + 4, F - 6 through F + 3, and C - 5 through C + 4. Biphasic curves were observed in 72 of the cycles (97.3%) and monophasic curves in 2 cycles (2.7%). In at least 5 of 74 cycles (6.8%) the BBT curve gave incorrect information on the ovulatory status of the cycle.

Natural family planning. I. The peak symptom and estimated time of ovulation.

The observation of the "Peak" mucus symptom in women using the ovulation method of natural family planning has been correlated with the estimated time of ovulation, as evaluated by indirect hormonal parameters. In 65 cycles of the 73 studied in 24 patients, there was hormonal confirmation of ovulation; in eight cycles, anovulation or luteal dysfunction was suspected. In the 65 normal cycles, 64 exhibited a Peak symptom. In those cycles, ovulation was estimated to occur from 3 days before to 3 days after the Peak symptom with a mean of 0.31 days before the Peak symptom. In 95.4% of these cycles, ovulation was estimated to occur from 2 days before to 2 days after the Peak symptom. The variation between cycles of the same patient ranged from 0 to 4 days with a mean of 1.8 days. The beginning of the mucus symptom preceded the estimated time of ovulation by an average of 5.9 days.

PIP: The purpose of this study of the ovulation method of natural family planning was to correlate the "Peak" mucus symptom with the estimated time of ovulation (ETO) and to note cyclic variations within a group of 24 women as well as in individual women. Criteria for entry into the study were: the recording of mucus observations and oral basal body temperatures for at least 3 cycles, a documentation of at least 3 cycles in which biphasic temperature curves were obtaining showing a luteal phase of at least 12 days. Serum samples were assayed for luteinizing hormone, estradiol-17 beta, and progesterone by radioimmunoassay. ETO was considered to have occurred during the time when the progesterone level was between 1 ng/ml and 2.3 ng/ml. Scores characterizing the mucus discharge were kept by the women and used for plotting the mucus cycle in correlation with hormone levels. Of the 73 cycles studied 65 were considered ovulatory. 64 cycles displayed a "Peak" symptom; ovulation in these was found to occur from 3 days before to 3 days after the "Peak" symptom; on average 0.31 days before the "Peak" symptom. In 95.4% of the 64 cycles it was estimated to occur from 2 days before to 2 days after the "Peak" symptom. The number of mucus days preceding the ETO averaged 5.9 days. The cyclic variation in correlation between the ETO and the "Peak" symptom in the individual woman averaged 1.8 days. In 63 of the 65 normal ovulatory cycles ETO coincided with the time of fertility as defined by the ovulation method. The findings of this study are in agreement with those of previous studies and would, it seems, justify future work to further clarify the method's application and the role of cervical mucus.