A one-year experience with a capitated health care plan for infertility.

OBJECTIVE: To report on a one-year experience participating in a capitated healthcare plan for infertility. DESIGN: Prospective study. SETTING: University population. PATIENT(S): Reproductive-age women 15 to 50 years. INTERVENTION(S): The first-generation Lewin infertility algorithm and CATHI software were used to negotiate infertility services under a capitated arrangement for $0.50 per member per month. The following reports our experience for the fiscal year 1997. MAIN OUTCOME MEASURE(S): Infertility services rendered, pregnancy rate, cost of services, collection rates. RESULT(S): Five thousand forty-six women representing 39,689 member months generated 39 new and 198 return visits. Thirty-two percent of the patients required three visits or less; six patients generated 22% of the visits. Fifty-one percent listed infertility as one of their chief complaints; 31% had mixed diagnoses. Eight (7.6%) patients required surgery, 11 (10.5%) patients underwent either IVF or GIFT cycles. Total charges submitted were $176,636; the amount assigned to specialty care was $135,277, and to IVF/GIFT, $33,433. Total capitated payments, including copayments, was $126,256 under the reproductive medicine agreement and $32,891 under the infertility rider. This resulted in a 71% gross collections rate. CONCLUSION(S): This study indicates that entering into a capitated health care plan to provide an infertility benefit can produce a successful result.

The holmium:yttrium-aluminum-garnet laser in wrist arthroscopy: a five-year experience in the treatment of central triangular fibrocartilage complex tears by partial excision.

Arthroscopic debridement of the articular disk is an accepted method for the treatment of symptomatic central tears of the triangular fibrocartilage complex. Current techniques use punches, knives, and shavers to debride the torn disk back to a stable peripheral rim. The holmium:yttrium-aluminum-garnet laser offers an alternative method for disk debridement with potential advantages of enhanced speed, precision, and hemostasis. We present a retrospective review of 35 patients who underwent arthroscopic laser debridement for a Palmer type IA tear in the triangular fibrocartilage complex. Overall response to treatment was good to excellent in 68% of patients and return to work was seen in 88%. One patient developed a deep wound infection. Clinical results after arthroscopic laser debridement are comparable to those reported by other investigators using conventional techniques.

Constructing a financial case for a computerized patient data management system (PDMS) in a cardiothoracic intensive care unit.

A number of claims are made for computerized patient data management systems (PDMS) which make them of interest to medical and nursing staff who wish to optimize patient care. Comparatively little has been published concerning cost effectiveness of these systems. In this article a financial case is put forward based on the premise that a PDMS can save nursing time, and this saving can then be translated into employing a smaller nursing workforce. An analysis of the relevant costs suggests that over an 8-year period these systems can show substantial profits, but it is also suggested that more research is required to substantiate this finding.

Hidden costs of infertility treatment in employee health benefits plans.

OBJECTIVES: Many employers exclude infertility treatment from coverage under their health benefits plans. However, infertility treatment is often provided under other diagnoses or in association with therapy rendered for other disease processes. This study attempted to estimate those hidden costs and to determine what the impact would be of providing coverage for infertility treatment. STUDY DESIGN: A 1-year retrospective analysis was carried out to isolate the hidden costs of infertility treatment from specific medical claims data gathered from a large representative employer with no infertility benefit provided. Data were analyzed in the context of the claims experience of a health plan covering approximately 28,000 employees. Infertility treatment was excluded under this plan. Medical claims for specific procedures and diagnoses in 1996 were analyzed by using Current Procedural Terminology codes in conjunction with International Classification of Diseases, Ninth Revision codes to estimate the hidden costs of infertility treatment. Forty-one Current Procedural Terminology codes and 68 International Classification of Diseases, Ninth Revision codes were used for the analysis. Clinical practice experience was used to set boundaries (conservative and moderate estimate) regarding the likelihood of a given treatment being associated with infertility. This was compared with 100% covered charges to generate claims per employee per month. Procedures covered operative, diagnostic, and laboratory services. These figures were used to compute a range of cost for infertility treatment per member per month. RESULTS: Forty-one Current Procedural Terminology codes were identified that indicated possible infertility treatment. These covered the areas of laparoscopic and hysteroscopic surgery, lysis of adhesions, neosalpingostomy, cyst drainage, oocyte retrieval or embryo transfer, echography, and various hormonal analyses. Sixty-eight International Classification of Diseases, Ninth Revision codes indicated the possibility of infertility treatment. These included endocrine disorders, various uterine pathologic conditions, pelvic pain, endometriosis, pregnancy loss, irregular menses, and various ovulatory dysfunctions. The retrospective analysis found that 35 Current Procedural Terminology codes were involved in claims highly indicative of infertility services, such as 56353, hysteroscopic division of uterine septum, and 58345, transcervical fallopian tube catheterization. According to the 35 Current Procedural Terminology codes, $603,807.95 would have been paid if 100% of the charges had been covered; this would have resulted in a claim per employee per month of $1.12 by conservative estimate to $0.60 by moderate estimate. Computed cost figures per member per month showed the hidden costs of infertility to range between $0.27 and $0.50. CONCLUSION: On the basis of various cost studies, rate filings, and employee data, the cost of providing coverage for infertility treatment has previously been shown to vary between $0.20 and $2.00 per member per month. Through appropriate cost sharing, managed care, and algorithms, infertility coverage can be offered at a cost of $0.40 to $0.50 per member per month. This analysis indicates that at least some employers already pay this much even when infertility is specifically excluded under the plan.

Peripheral progesterone (P) levels and endometrial response to various dosages of vaginally administered P in estrogen-primed women.

OBJECTIVE: To compare the pharmacokinetics and pharmacodynamics of 100 mg/d, 200 mg/d, and 400 mg/d (200 mg two times per day) of P administered vaginally for 14 days to estrogen-primed postmenopausal women. DESIGN: Randomized, open-label, three-way crossover study. SETTING: Two university-based investigative sites. PATIENT(S): Twenty healthy postmenopausal women with histologically normal endometria. INTERVENTION(S): Oral 17 beta-E2 was given each day of a 28-day cycle; a P vaginal suppository was inserted daily according to the randomization schedule during days 15-28 of each cycle; blood samples were collected; an endometrial biopsy was obtained on day 25; and patients were crossed over to the next treatment cycle after a washout period of at least 30 days. MAIN OUTCOME MEASURE(S): Mean P blood levels, endometrial dating/conversion. RESULT(S): There was good vaginal absorption of P for all dosages. Endometrial conversion occurred in all 200- and 400-mg/d P-dosed cycles, whereas the 100-mg/d dosage failed to convert primed endometria consistently. There also was a significantly increased tendency for earlier bleeding and spotting with the 100-mg/d dosage. CONCLUSION(S): Both the 200- and 400-mg/d dosage regimens consistently convert an estrogen-primed endometrium, and yield appropriate endometrial dating and bleeding patterns. However, the 400-mg/d dosage attains the highest sustained blood levels and may be the best dosage regimen for further study.

Identification of early pregnancy landmarks by transvaginal sonography: analysis by logistic regression.

OBJECTIVE: To assess the feasibility of logistic regression analysis for determining the gestational ages at which detection of early pregnancy landmarks first can be observed. DESIGN: Retrospective analysis. SETTING: University-based tertiary care clinic. PATIENT(S): Eighty-two women with viable singleton pregnancies in whom ovulation had been achieved by an injection of hCG. INTERVENTION(S): Two hundred fifteen transvaginal sonographic scans. MAIN OUTCOME MEASURE(S): Logistic regression was used to estimate the probability of detection of sonographic findings as a function of gestational age. RESULT(S): We found that the likelihood of visualization of a gestational sac or fetal heart motion could be represented accurately by logistic equations. Gestational age at which there was 95% probability of visualization was 35.5 days for the gestational sac and 44.5 days for fetal cardiac activity. The probability of detecting fetal cardiac activity was 95% when the mean gestational sac diameter was 1.6 cm and was 99% at 1.9 cm. CONCLUSION(S): The sonographic appearances of developmental landmarks in early pregnancy occurs within well-defined gestational time periods, and the probabilities for visualization can be closely approximated using a logistic model. Our results suggest that the number of sonographic examinations required to document infertility treatment success can be minimized by surveillance at standardized gestational ages.

The effect of routine breast examination on serum prolactin levels.

OBJECTIVE: To evaluate the effect of a routine breast examination on serum PRL levels. DESIGN: Prospective clinical study. SETTING: University-based reproductive endocrinology unit. PATIENTS: Eleven nonlactating, euprolactinemic women of reproductive age with a history of regular menstrual cycles and currently taking no medications. INTERVENTIONS: Breast examination using standard technique. MAIN OUTCOME MEASURE: Changes in serum PRL levels after breast examination. RESULTS: Baseline PRL levels ranged from 3.64 to 19.23 ng/mL (mean 7.17 ng/mL; conversion factor to SI unit, 1.00). There were no significant increases in PRL levels after breast examination, with mean PRL levels after 15, 30, and 45 minutes of 6.59, 6.84, and 6.45 ng/mL, respectively. CONCLUSION: Routine breast examination does not alter acutely serum PRL levels in normal women.

Hyperprolactinemia. Evaluation and management.

Hyperprolactinemic syndromes are a diverse group of disorders that present in widely different age groups. They are common disorders in both men and women and require management over a lifetime. The past 20 years have greatly increased our knowledge about these disorders and simplified their management. Yet, we have made little progress in understanding the origin and dynamics of pituitary tumors and their natural histories, and as yet we have been unable to develop effective tumoricidal therapy or medication that corrects, at the central axis level, neurotransmitter disorders that may produce hyperprolactinemia. Perhaps these issues will be the subject of such reviews in the future.

Visualization of free peritoneal fluid with transvaginal sonography. A preliminary study.

Visualization of free peritoneal fluid during sonographic examination is often of considerable clinical importance. To determine the sensitivity of transvaginal sonography in the detection of this finding, measured amounts of isotonic saline were instilled into the abdominal cavities of 15 women undergoing diagnostic laparoscopy while a 5-MHz transvaginal probe was employed to view the pelvic contents. Small amounts of free fluid could be visualized easily in all the patients (mean +/- SD, 25.8 +/- 6.4 mL). Fluid was first seen in the cul-de-sac in 10 patients and in the adnexal region in 5. When fluid instillation was continued to a total volume of 200 mL, the pelvic viscera were distinctly outlined in all the patients, markedly enhancing visualization of the uterus, tubes and ovaries. Transvaginal sonography seems to be a sensitive and reliable method of detecting free peritoneal fluid. Instillation of fluid into the peritoneal cavity may be a clinically useful technique for enhancing the sonographic visualization of pelvic structures.

Applications of laser surgery in gynecology. Hype or high tech?

Despite the proliferation of the use of lasers in gynecology, physicians in both private practice and the academic setting remain skeptical about the role of these instruments. The laser has not made it possible to perform surgical procedures that have previously been impossible to carry out in the operating theater. Further, as yet, higher pregnancy rates have not been achieved with any reconstructive procedure using the laser rather than conventional or electrocautery surgery. On the other hand, surgeons such as Daniell reported on the impact of laser in decreasing the need for laparotomy in their practices. For instance, prior to the introduction of the laser, Daniell performed laparotomy on 80% of his patients with endometriosis, pelvic adhesive disease, or tubal disease, whereas currently he performs 80% of these procedures through the laparoscope. However, one could argue that this change simply represents the trend of performing more gynecologic procedures through endoscopes whether a laser is involved or not. Convincing evidence exists that pelviscopy results in savings in terms of morbidity and the cost of surgery. Whether endoscopic surgery can be performed more safely using the laser than with a traditional technique has not been addressed in a formal study. Whether laser surgery produces better pregnancy rates is unresolved. Ninety per cent of all clinical trials involving the laser have been uncontrolled. Those studies that have been controlled, reported by Tulandi, for example, have shown results at least equivalent to those achieved with diathermy, and it is of interest that the pregnancies tended to occur sooner in the laser-treated groups. The laser is at least as effective as electrocautery in the treatment of adhesions and distal tubal disease. Therefore, it is the author's recommendation that all types of lasers be used in conjunction with electrocautery and conventional sharp dissection in the treatment of various forms of pelvic pathology. It is important that surgeons become familiar with all types of lasers, as future devices may be vastly different and prove to be clearly superior in treating the various pelvic pathologies.

Effect of estrogen/progestin administration on the ovarian response to gonadotropins: a randomized, prospective study.

The findings of our study indicate that women pretreated with E/progestin demonstrate increased gonadotropin requirements when undergoing ovulation induction. Whether this treatment has a significant effect on the outcome of ovulation induction in patients receiving gonadotropins remains to be established.

Hormonal treatment of functional ovarian cysts: a randomized, prospective study.

Estrogen (E)/progestin therapy for functional ovarian cysts is widely used in clinical practice, but the efficacy of this treatment has not been determined in controlled trials. In this study, we examined the effect of E/progestin administration in a group of infertility patients enrolled in a program of ovulation induction who had cysts identified by transvaginal sonography. Patients were randomized to receive either norethindrone 1 mg/mestranol 0.05 mg/d (group A, n = 24) or no treatment (group B, n = 24) for up to 6 weeks. Patients were re-evaluated by sonography at 3, 6, and 9 weeks after entry into the protocol. The ages, mean cyst diameters, and proportions of patients having received gonadotropins in the previous menstrual cycle were not significantly different among the two groups. All patients who had a sonographic abnormality persisting for 9 weeks were surgically explored and found to have pathological cysts. The rate of disappearance of functional ovarian cysts was not affected by E/progestin treatment.

Detection of antigalactosyltransferase antibodies in plasma from patients with antisperm antibodies.

Sperm-associated galactosyltransferase has been implicated as a macromolecule involved in sperm to egg binding interactions during fertilization. An analysis of human plasma from 18 patients with antibodies to sperm antigens detected antigalactosyltransferase antibodies when compared with 10 control patients. These plasma antibodies were all able to immunoprecipitate enzyme activity from a preparation of human milk galactosyltransferase but varied in their ability to detect the protein by Western blot analyses. These results confirm the antigenic presence of galactosyltransferase in human sperm.

Secretory immune system of the female reproductive tract. II. Local immune system in normal and infected fallopian tube.

The existence of a secretory immune system in the female genital tract has been demonstrated by the predominance of immunoglobulin (Ig)A-producing plasma cells in human fallopian tube, uterine cervix, and vagina. Epithelium lining fallopian tubes expresses a receptor for IgA, secretory component (SC), and thus resembles other secretory tissues such as intestine, mammary, lacrimal, and salivary glands. The present study extends the characterization of the local immune system in the fallopian tube and assesses its response to infection. We examined normal and infected fallopian tubes from surgical specimens, obtained at tubal ligation and abdominal hysterectomy, for the presence of Ig-producing cells, T cells, and natural killer cells. All tubular segments contained a predominance of IgA plasma cells in the subepithelial lamina propria. The epithelial cells were strongly positive for SC. Luminal contents stained positively for IgA, SC, and J chain, suggesting that this material contained secretory IgA. Submucosal plasma cells of IgM and IgG classes were less frequent than IgA. T cells were present in numbers approximately twofold greater than plasma cells in normal fallopian tubes. T-suppressor (CD8+) cells, which may function in the induction of immune tolerance, were present in the intraepithelial spaces. Infected segments of fallopian tubes demonstrated six- to tenfold increased numbers of plasma cells of all classes. These data suggest that a local immune system is functioning in the human fallopian tube and may provide a first line of defense against tubal infection and the prevention of tubal factor infertility.

Performance anxiety during infertility treatment: effect on semen quality.

The requirement to obtain a semen sample at a specific time for an infertility treatment procedure has potential to produce considerable performance anxiety. This study was designed to evaluate the semen quality of men participating in infertility treatments associated with heightened performance anxiety. The most recent pretreatment semen analysis and the infertility treatment semen analysis, as well as the first and last procedure semen analyses, were compared using paired t-tests for 77 patients undergoing assisted reproductive technology procedures and 121 patients undergoing intrauterine insemination. No significant differences were noted in either of these groups of patients. However, in men with total motile sperm counts of less than 40 million, semen parameters improved significantly in the procedure semen analyses. Thus, participation in infertility treatments associated with performance anxiety does not appear to be detrimental to semen quality, and in certain groups of patients semen quality may improve.

Comparison between 1-hour and 24-hour follow-up radiographs in hysterosalpingography using oil based contrast media.

A comparison was made between oil-contrast hysterosalpingogram (HSG) with 1-hour follow-up radiograph and the traditional 24-hour follow-up radiograph with respect to detection of tubal patency and pelvic adhesive disease. The results on either modality were assessed by subsequent laparoscopy. The 1-hour HSG was comparable to the 24-hour HSG in defining tubal patency. Even though it was inferior to the 24-hour HSG with respect to identifying pelvic adhesions, it may serve as an adequate substitute to the above since the sensitivity of the HSG in identifying adhesions is low and has little influence on the clinical decision process in the evaluation of infertility.

Identification of a deoxyribonucleic acid allelic variant for beta 1-4 galactosyltransferase expression associated with male sperm binding/penetration infertility.

Studies on mouse sperm-egg binding and fertilization have been suggested to involve the interaction of sperm-associated beta 1-4 galactosyltransferase with egg zona pellucida glycoproteins. A population of human males, whose sperm demonstrated an inability to penetrate ovulated zona pellucida-free hamster eggs in vitro, were examined for the level of activity of beta 1-4 galactosyltransferase. The level of enzyme activity was found to be reduced in human sperm isolated from this group of individuals compared with a known hamster penetration-positive group. Analysis of the deoxyribonucleic acid from these individuals by Southern hybridization with a putative human complementary deoxyribonucleic acid clone to beta 1-4 galactosyltransferase identified a unique allele lacking 0.8 and 0.4 kb restriction fragments on digestion with the endonuclease Taq I. These results represent the first evidence to suggest that mutations could be associated with the human gene for galactosyltransferase. Our data help to clarify one of the possible molecular mechanisms responsible for sperm-egg binding/penetration interactions.

CV 205-502 treatment of hyperprolactinemia.

CV 205-502 is a nonergot oral dopamine agonist with specific D2 activity, which has a prolonged suppressive effect on serum PRL and may have fewer side-effects than other dopamine agonists. We treated 26 hyperprolactinemic women with this compound given as a single bedtime (hs) dose for up to 12 weeks. All had gonadal dysfunction, either amenorrhea or oligomenorrhea, and 15 had galactorrhea. The initial and subsequent doses were administered in a randomized fashion; the initial dose ranged from 0.01-0.05 mg, and the dose at 12 weeks ranged from 0.03-0.09 mg. The women were evaluated every 2 weeks, and the dose was increased by 0.02 mg every 4 weeks if the serum PRL level was greater than 20 micrograms/L. Of the 26 women initially enrolled, 24 completed 12 weeks of therapy, and 2 discontinued therapy because of side-effects. Thirteen women (54%) had return of menses, and 12 (80%) had either a decrease in or disappearance of galactorrhea. Serum PRL concentrations decreased to a variable degree in all patients; 13 (54%) achieved a normal serum PRL level (less than or equal to 20 micrograms/L). The mean (+/- SE) pretreatment serum PRL concentration was 129 +/- 34, and it was 29.9 +/- 5.9 micrograms/L after 12 weeks of treatment (P = 0.005). The mean (+/- SE) percent reduction in serum PRL was 66.5 +/- 5.0% (median, 78.0%). A dose response was not demonstrated (r = -0.08; P = 0.70) among the 6 dose groups during the last 4 weeks of therapy. In 5 women, serum PRL levels, measured frequently for 24 h after treatment remained low. Side-effects after the initiation of therapy included nausea, headache, and morning fatigue in 10 women. These symptoms caused 2 women to discontinue therapy; they subsided in the other women. An optimal dose was not determined and will probably need to be determined by titration in each patient. CV 205-502, given once daily, appears to be a safe and effective alternative to other dopamine agonists in the treatment of hyperprolactinemia.