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Evaluation of the accuracy of the home ovulation detection kit, Clearplan, at predicting ovulation.

A home ovulation testing kit, Clearplan, that detects the urinary luteinizing hormone (LH) surge was compared with basal body temperature (BBT) charts and cervical scoring as a method of ovulation prediction in 54 consecutive patients. The accuracy of all these methods was evaluated using daily serum LH measurements. Clearplan was shown to be significantly more accurate at timing ovulation than were BBT charts (P less than 0.0001) and cervical scoring (P less than 0.025). In 82%-88% of cases the kit predicted ovulation within one day and in 89%-96% of cases within two days of the serum LH surge. The kits were found to be easy to use and their potential place in clinical practice is discussed; home ovulation testing may ultimately replace serum LH assays as the method of choice in timing ovulation.

Body Temperature

Ovulation detection.

Despite major achievements in elucidating many details of the physiologic processes of human reproduction during the past 2 decades, a simple, reliable, and inexpensive method for the prediction and detection of the time of ovulation is still not available. For clinical purposes, studies of BBT and biophysical and biochemical constituents of cervical mucus appear to be the most practical methods of ovulation detection. The development of rapid and easy-to-use urinary LH assays and steroid assay kits for measurement of urinary and salivary estrogen and progesterone or their metabolites may further improve the precision of ovulation timing.

Biopsy

A novel approach for monitoring the endometrial cycle and detecting ovulation.

We report the presence of a cycle-dependent sialoglycoprotein in the endometrium. A monoclonal antibody (D9B1) to this glycoprotein has been derived and used to study tissue from 24 women with normal menstrual cycles. Results obtained with peroxidase immunohistochemistry suggest a highly significant variation in concentration of the glycoprotein, which is absent in the proliferative phase and present at maximal levels in the early secretory phase. The amount of antigen then diminishes slowly through the latter part of the secretory phase. The glycoprotein is produced in epithelial cells of glands and uterine lumen before being secreted across the apical cell surface. The secretory response is uniform in different areas of the tissue and within individual glands. However, considerable differences in secretory activity can be observed between adjacent glands in any part of the endometrium. Binding of the antibody is shown to be a new and novel parameter in characterization and standardization of the normal function of endometrium in response to ovarian hormones.

Antibodies, Monoclonal

Use of vaginal concretions of calcium carbonate to detect ovulation in hamsters.

Concretions of calcium carbonate normally appear every third and fourth da of the 4-da hamster cycle da 1 = day of ovulation). We presently found that the 2-da relation between ovulation and concretion formation was maintained even after ovulation was delayed 1 or more da by centrally acting drugs or by exposing the hamsters to constant light. It is therefore possible to identify days of ovulation in vaginal washing records of both normal and treated hamsters by counting back 2 da from each sequence of concretions.

Animals

Human urinary glycosaminoglycans as accurate method for ovulation detection.

Urinary glycosaminoglycans (GAGs) content showed a characteristic pattern of fluctuation during normal and hormonally induced cycles with a distinct peak at ovulation. This peak of maximal GAGs concentration (106.7 +/- 46.2 micrograms/mL in urine) was centered according to the day of the midcycle LH surge, which serves as the reference point, designated day 0. All cycles are presumed to be ovulatory on the basis of biphasic BBT nadir, ultrasonographic studies, and progesterone assays (greater than 5 ng/mL of serum) during the secretory phase. In hormonally induced menstrual cycles, a noticeable increase in GAGs concentration (70%) was observed. This indirect evidence suggests a possible correlation between GAGs content and hormonal effect. All types of GAGs, with the exception of heparin, have been found in urine, chondroitin sulfate C being the major component at time of ovulation. These results strongly suggest that urinary GAGs determination is a precise method for ovulation detection.

Adult

A rapid method for ovulation detection.

Uronic acid (UA) content in whole urine showed a characteristic pattern of fluctuations during menstrual cycle (24 cycles) with a distinct peak on the day of ovulation (midcycle peak 1043 + 68 micrograms/ml urine. This peak of maximal UA concentration was validated by ultrasonography (abdominal and/or vaginal scanner and basal body temperature. In hormonal induced menstrual cycle (5 cycles) a significant decrease in Ua concentrations were observed during the follicular phase (20%) and in the midcycle peak (11%) when they were compared with the same values in the normal cycle. Nevertheless, two days after the ovulation peak occurs a second peak can be observed (1344 + 799 micrograms UA/ml urine). On the other hand in the anovulatory cycles (5 cycles) the same diminishing behavior in the UA concentrations were observed in both phases of the cycle (50-60%) with the expected lack of the midcycle peak. Results that clearly show that UA excretion in urine reflect a excellent correlation with the menstrual cycle allowing us to propose this technique as an accurate and reliable method to detect ovulation.

Adult

The use of clearplan home ovulation detection kits in unexplained and male factor infertility.

One hundred and five couples with unexplained infertility and 43 couples whose infertility was thought to be due to reduced sperm motility were recruited. The median duration of infertility was 36 months (range 12-168). Couples were randomly allocated to either using Clearplan home ovulation detection kits for 3 cycles or were advised about the optimal time during their menstrual cycle to achieve a pregnancy. The clinical details of the 2 groups were similar. In couples with unexplained infertility over the study period 10 (20.4%) in the Clearplan group and 9 (16%) in the control group conceived with 58% of pregnancies occurring in the first cycle. In couples with reduced sperm motility, the results were disappointing with only 2 (8%) pregnancies in the Clearplan group and 2 (11.1%) in the controls. Assisted reproduction technology may not be justified as the first line of management in patients with unexplained infertility.

Adult

The clinical value of Clearplan home ovulation detection kits in infertility practice.

A home ovulation testing kit, Clearplan, that detects the urinary luteinizing hormone (LH) surge was used by 32 patients on a donor insemination programme for 50 cycles to indicate when to first attend the clinic for a serum LH test to determine ovulation. Using Clearplan significantly reduced the number of clinic attendances (4.06 +/- 1.5) compared to the preceding control cycle (7.06 +/- 2.0 p less than 0.001). One serum LH peak was missed using Clearplan. Ovulation was predicted within 2 days of the serum LH surge in 77% of cycles. Home ovulation determination has the potential to reduce the stress and cost of fertility programmes.

Appointments and Schedules

Pregnancy and ovulation detection in bison (Bison bison) assessed by means of urinary and fecal steroids.

Sexually mature bison (Bison bison) cows were tested for both pregnancy and ovulation by means of urinary steroid metabolites and fecal steroids. The accuracy of pregnancy diagnosis was determined among 18 bison cows, in approximately the third month of gestation, by means of urinary pregnanediol-3 delta-glucuronide (PdG), urinary estrone conjugates (E1C), and fecal total estrogens (TE). Urinary PdG was 100% accurate, urinary E1C was 89% accurate, and fecal TE was 100% accurate in predicting pregnancy. Fecal progesterone (P4) and TE, as well as urinary E1C and PdG concentrations all increased from conception (August) through January, but significant differences were not apparent until November. During the rutting season ovulation was detected by increases in either urinary PdG or fecal P4 concentrations. Both pregnancy and ovulation were detected in uncaptured bison with reasonable accuracy by means of urinary and fecal steroids or their metabolites.

Animals

Evaluation of a semiquantitative urinary LH assay for ovulation detection.

Levels of urinary LH were determined by a rapid, semiquantitative enzyme immunoassay dipstick test (Ovustick, now known as OvuKIT) and the results were compared with a standard serum LH double-antibody radioimmunoassay in 63 cycles of 47 women undergoing stimulated cycles for in vitro fertilisation. A good correlation was found between the two assay methods in 70% of the cycles. An increase in serum LH was associated with a concurrent rise in the dipstick measurement. Using the Ovustick method, no false-positive finding was encountered, but the LH rise was missed in one case. The number of mature oocytes aspirated was significantly higher in the stimulated cycles without an endogenous LH surge. The use of this simple and rapid enzyme immunoassay method makes possible successful and precise timing of ovulation during artificial insemination or egg retrieval for IVF in treatments for infertility.

Evaluation Studies as Topic

Ovulation detection and timing of insemination based on hormone concentrations, vaginal cytology and the endoscopic appearance of the vagina in domestic bitches.

The fertilization period, the time when fertilization can occur, can best be determined using a combination of vaginal cytology and morphology of the vaginal mucosa, behaviour and endocrinology. Neither vaginal cytological changes nor standing oestrus are reliable indicators of the fertilization period per se although with natural mating or when using AI with fresh semen there may be enough biological leeway for pregnancy to follow insemination timed using these parameters alone. This is indicated by the well recognized fecundity of bitches mated early or late in oestrus. Precise discrimination of the fertilization period, which is often required and is necessary for AI using frozen semen, can be achieved by using vaginoscopy to detect the onset of shrinkage with angulation of the mucosal folds. Vaginoscopy is also useful to determine the probable end of the fertilization period and the transition to a 'metoestrous' vaginal smear is also useful in this regard. Detection of the LH peak enables the start of the fertilization period to be forecast quite precisely but, in lieu of practical assays with which to measure plasma LH, a rise in plasma progesterone concentration to 6-8 ng/ml may be more practical.

Animals

Accuracy of basal body temperature for ovulation detection.

In 30 normally menstruating women, ages 19 to 41 (mean 24), gravida 0 to 5 (mean 0.7), basal body temperature (BBT) was correlated with serum luteinizing hormone (LH), progesterone, and estradiol or urinary estrogen levels assayed serially during one menstrual cycle. In 21 subjects (70%), a biphasic BBT correlated with an ovulatory hormonal pattern. Six women (20%) had a monophasic BBT but demonstrated a preovulatory estrogen peak, a midcycle LH surge, and a significant rise in serum progesterone levels during the luteal phase. The remaining three women (10%) showed anovulatory cycles (two women) or a deficient luteal phase (one woman) as determined by BBT and hormonal assays. The results indicate that in approximately 20% of ovulatory cycles the BBT failed to demonstrate ovulation.

Adult

A prototype for ovulation detection: pros and cons.

A noninstrumented enzyme immunoassay for urinary estrone conjugates was adapted from an instrumented microtiter plate enzyme immunoassay assay. The end point of the assay was a color change from green to clear, which was visible to the unaided eye. The visible color change was adjusted to allow 80 ng/ml estrone conjugates (on the basis of a sample size of 6.5 microliters urine) to be distinguished from an infinite dilution without instrumentation. The evaluation of human urine collected from ovulatory ovarian cycles demonstrated that early follicular phase concentrations (35.9 +/- 6.8 to 79.4 +/- 14.7 ng/ml, n = 10) produced a dark-green color, whereas late follicular phase concentrations (162.9 +/- 20.1 ng/ml, n = 10) produced no color. Daily urine samples throughout 10 ovulatory ovarian cycles produced parallel profiles when compared to measurements of estradiol in paired blood samples. Complete analysis of the data indicated that ovarian follicular dynamics can be accurately monitored through the noninstrumented analysis of daily estrone conjugates in urine samples.

Adult

[Sonographic prediction and detection of ovulation].

The aim of the study was to define the role of sonography as a separate method in prediction and confirmation of ovulation. The growth of the follicle over the period from the 10th to the 17th day of menstruation was sonographically followed-up in 63 spontaneous and induced cycles. It was found that sonography was a quick and simple method. As separate method it can be used for the confirmation of ovulation, prevention of hyperstimulated ovarian syndrome and determination of the best time for artificial insemination. In combination with the other procedures it is convenient for prediction of ovulation.

Female

Inability of sonography to detect imminent ovulation.

Sonographic visualization of the cumulus oophorus or of morphologic alterations in the wall of the dominant follicle have been reported to be reliable signs of imminent ovulation when conventional transabdominal sonography is used. To determine if transvaginal sonography could allow a more frequent and confident prediction of imminent ovulation, we prospectively monitored 22 ovulatory menstrual cycles in four women undergoing artificial insemination and in 13 normally menstruating volunteers. Scanning was done on alternate days in the periovulatory period; a 7.5-MHz transvaginal transducer was used. Despite the improved resolution obtained with transvaginal sonography, confident identification of the cumulus oophorus or of mural changes in the follicle was not possible in any of the cycles followed. No other consistent follicular characteristic predicted imminent ovulation. We conclude that confident prediction of imminent ovulation is not possible with sonographic analysis.

Adult