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PubMed2001

Noncompliance among a group of women using a novel method of contraception.

OBJECTIVE: To compare the incidence of noncompliance measured objectively by a home use fertility monitor with the traditional self-reported incidence of compliance in a study of a new method of contraception. DESIGN: Prospective cohort study. SETTING: A large family planning clinic in Edinburgh. PATIENT(S): Thirty-two healthy women who took part in a trial assessing the efficacy of a novel method of contraception involving accurately timed administration of a single dose of mifepristone. INTERVENTION(S): Mifepristone was administered orally and a blood sample was collected on the same day. MAIN OUTCOME MEASURE(S): Percentage of missed tests detected by the monitor against the self-reported percentage during the critical period. RESULT(S): Women failed to perform 24.2% (95% confidence interval, 16.5-31.5) of the tests in the 162 cycles analyzed. They missed tests at an absolutely vital time for contraceptive efficacy in 42% of cycles according to the monitor while admitting to missing tests in 14.8%. Poor compliance was associated with younger women, those who discontinued the study before completion, and cycles in which women were not relying on the contraceptive method. CONCLUSION(S): The use of microelectronic monitoring systems may improve our understanding of the extent of patient noncompliance, providing objective information that no other monitoring technique can produce. This understanding provides the opportunity to make the optimum use of potentially effective treatments while validating research evidence.

Cohort Studies↗
PubMed2006

The Oxford Conception Study design and recruitment experience.

The Oxford Conception Study is a randomised controlled trial that aims to determine whether or not information about potential fertility from a device that monitors urinary hormones will increase the conception rate in women wishing to conceive. Three modified versions of a fertility monitor have been developed for the study. The monitor measures the levels of urinary oestrone-3-glucuronide (E3G) and luteinising hormone (LH), and the display indicates high or low fertility. The monitor requests all women to test their urine from day 6 to day 25 of the menstrual cycle inclusive. One-third of women are randomised to receive information from the fertility monitor about the early fertile time (from the first rise in E3G until the LH surge is detected), one-third receive information about the late fertile time (the onset of the LH surge and the following 2 days), and a third do not receive any information (control group). All the women are followed up for 6 months or until they are pregnant. A total of 1453 women have been recruited into the study, reaching the study recruitment goal for 80% power to detect a 10% difference in three-cycle pregnancy rate between the Late Fertile Time group (50%) and the Control group (40%), allowing for a 15% non-pregnancy drop-out rate. Follow-up of the women is currently ongoing. The primary analysis will compare the cumulative three-cycle pregnancy rate between each of the study arms. Time-specific conception probabilities will be estimated from coitus information recorded in 12-h intervals. The data from this study will also allow many additional questions to be addressed, including changes in intercourse patterns with feedback about the fertile days and other questions in relation to menstrual cycle function, sexual intercourse, stress, exposures to tobacco products, alcohol, caffeine and medications, fertility and pregnancy outcomes. In addition to presenting the study design, we review the recruitment experience for the Oxford Conception Study. We have achieved sustained and effective recruitment over time by primary use of recruiting via the Internet.

Adolescent↗
PubMed1989

Efficacy of the urinary hemagglutination test (Higonavis) and enzyme immunoassay (Ovustick) in detection of the spontaneous luteinizing hormone surge in an in vitro fertilization/gamete intrafallopian transfer (IVF/GIFT) program.

Fifty-eight treatment cycles in an in vitro fertilization/gamete intrafallopian transfer (IVF/GIFT) program were studied to compare the efficacy of two urinary methods, hemagglutination test (Higonavis) and enzyme immunoassay (Ovustick), in detection of spontaneous luteinizing hormone (LH) surge. If an isolated rise in urinary LH level was taken as indicative of LH surge, the false-positive rate was 36.7% for Higonavis and 10.2% for Ovustick. The difference was statistically significant (P less than 0.001). If only a sustained rise in urinary LH was taken to indicate LH surge, the false-positive rate was 6.1% for Higonavis and 0% for Ovustick. In the seven cycles with a spontaneous plasma LH surge, there was a positive correlation between the plasma LH levels and the two urinary assay methods in six cycles (85.7%). Compared to plasma LH, there was a mean delay of 17.4 hr by the Higonavis test and 15.6 hr by the Ovustick test. If a sustained rise in urinary LH levels was taken as indicative of LH surge, both methods are quite accurate but the Ovustick appeared to be more specific.

Evaluation Studies as Topic↗
PubMed1983

Mode of action of dl-norgestrel and ethinylestradiol combination in postcoital contraception. III. Effect of preovulatory administration following the luteinizing hormone surge on ovarian steroidogenesis.

A combination of 1.0 mg dl-norgestrel and 0.1 mg ethinylestradiol was administered orally at 18 hours after the detection of luteinizing hormone rise and again at 30 hours in five healthy volunteers with normal menstrual cycles. The effects on ovarian function were studied by comparing the daily serum levels of progesterone (P), 17 alpha-hydroxyprogesterone, and estradiol (E2) measured in a control (placebo) cycle with those in two consecutive treatment cycles. Treatment did not alter the steroid levels in one subject. P was suppressed in one or both treatment cycles of four subjects. E2 was suppressed in both treatment cycles of one subject and produced widely fluctuating patterns in another. The hormonal patterns in the two consecutive treatment cycles of the same individual were similar in all but one instance, where only the P level in the second treatment cycle was diminished. These results showed that this treatment can elicit steroidogenic responses of varying degrees and duration. The contraceptive action may lie in the altered P and/or E2 level at certain points in the menstrual cycle.

17-alpha-Hydroxyprogesterone↗
PubMed2002

Postovulatory effect of repeated administration of prostaglandin F2alpha on the endocrine status, ova transport, binding of accessory spermatozoa to the zona pellucida and embryo development of recently ovulated sows.

We investigated the postovulatory effect of repeated administration of prostaglandin F2alpha (PGF2alpha) on the endocrine status, ova transport, binding of accessory spermatozoa to the zona pellucida (ZP) and embryo development of recently ovulated sows. We used altogether 10 Swedish crossbred (Landrace x Yorkshire) multiparous sows. The treatment group (P-group) was administered 1 mg of PGF2alpha intravenously every 6 h via an indwelling jugular cannula, commencing 4-8 h after ovulation was detected in the second estrus after weaning. All sows were inseminated once and blood was sampled until the end of the experimental period. After slaughter, we immediately recovered the reproductive tracts and divided them into three equal isthmic segments (IST1, IST2 and IST3) and a third of the uterine horn from the utero-tubal-junction (UTJ), and we flushed each one with PBS for ova recovery. We immediately stained the ova and examined them under epi-fluorescence illumination. We found the highest proportion of ova in the P-group in IST1 (41.5%), while we found the highest proportion in the C-group in the uterus (40.7%). A total of 68.7% of ova in the P-group had more than 50 accessory spermatozoa attached to the ZP, compared with 36.7% in the C-group sows. A total of 77% of ova had more than three blastomeres in the P-group, compared with 73% in the C-group. PGF2alpha metabolite and cortisol levels were elevated (P < 0.05) following every PGF2alpha administration. Despite peaks, we saw no changes (P > 0.05) in progesterone levels between the P-group and the C-group. We saw no differences (P > 0.05) in estradiol-17beta levels between the P-group and the C-group. We concluded that PGF2alpha stimulates the hypothalamus-pituitary-adrenal axis, as evidenced by the elevation of cortisol and progesterone but not estradiol-17beta. Furthermore, repeated PGF2alpha administration might be associated with a delayed ova transport and an increased number of accessory spermatozoa bound to the ZP. However, the effect of PGF2alpha on embryo development is unclear.

Animals↗
PubMed1983

Ultrasonic signs of imminent ovulation.

Two consistent signs of imminent ovulation in the Graafian follicle have been identified using ultrasound. These signs are a line of decreased reflectivity around the follicle and a crenation pattern within the follicle. The signs may be useful in programs such as in vitro fertilization and artificial insemination, in which timing of ovulation is critical.

Female↗
PubMed1989

Distribution and role of microfilaments during early events of sheep fertilization.

The distribution of actin was studied during early events of sheep fertilization by fluorescence microscopy after staining with 7-nitrobenz-2-oxal-1.3 diazole (NBD)-phallacidin and anti-actin antibody and by electron microscopy after heavy meromyosin labelling. unfertilized and fertilized eggs exhibited a continuous band of fluorescence with both NBD-phallacidin and anti-actin antibody. Unlike in mice, no high concentration of actin overlying the spindle was detected in ovulated sheep oocytes. At the site of sperm head incorporation, the fertilization cone developed above the decondensing male chromatin and was underlined by a submembranous area rich in microfilaments. A similar actin network was observed in the cortex of the second polar body. Cytochalasin D was used to investigate the role of actin during the fertilization process. This drug did not prevent sperm fusion and incorporation but inhibited polar body abstriction and fertilization cone development and retarded sperm tail incorporation. Moreover, in the presence of the drug, the anchorage of the metaphase II spindle at the surface of the egg was destroyed. The role of microfilaments in these early events is discussed.

Actins↗
PubMed1991

Using the ratio of urinary oestrogen and progesterone metabolites to estimate day of ovulation.

We have developed a method of estimating day of ovulation using urinary ovarian hormone data. The method identifies a day of luteal transition that occurs at the shift from production of follicular oestrogen to luteal progesterone. The algorithm for identifying this shift was evaluated and judged better than specified alternatives in that it resulted in (1) a high concordance between the day of luteal transition and peaks in urinary luteinizing hormone (LH) for cycles with well-defined peaks, (2) a low variance in the length of the luteal phase of the menstrual cycle, which presumably reflects a low measurement error in estimating day of ovulation, and (3) a high proportion of cycles for which an approximate day of ovulation could be determined. To validate the new algorithm, it was applied to an independent data set. The algorithm identified a day of luteal transition in 88 per cent of these cycles, and the identified day occurred within two days of the urinary LH peak for all the cycles with clear LH peaks. Determination of the day of luteal transition to estimate ovulation requires only first-morning urine specimens, requires no correction for day-to-day variations in urine concentration, and can be applied to a mid-cycle window of data.

Algorithms↗
PubMed2001

Assessing human fertility using several markers of ovulation.

In modelling human fertility one ideally accounts for timing of intercourse relative to ovulation. Measurement error in identifying the day of ovulation can bias estimates of fecundability parameters and attenuate estimates of covariate effects. In the absence of a single perfect marker of ovulation, several error prone markers are sometimes obtained. In this paper we propose a semi-parametric mixture model that uses multiple independent markers of ovulation to account for measurement error. The model assigns each method of assessing ovulation a distinct non-parametric error distribution, and corrects bias in estimates of day-specific fecundability. We use a Monte Carlo EM algorithm for joint estimation of (i) the error distribution for the markers, (ii) the error-corrected fertility parameters, and (iii) the couple-specific random effects. We apply the methods to data from a North Carolina fertility study to assess the magnitude of error in measures of ovulation based on urinary luteinizing hormone and metabolites of ovarian hormones, and estimate the corrected day-specific probabilities of clinical pregnancy. Published in 2001 by John Wiley & Sons, Ltd.

Algorithms↗
PubMed1983

Timing of ovulation and implantation in the common marmoset, Callithrix jacchus, by monitoring of estrogens and 6 beta-hydroxypregnanolone in urine.

Urinary estrogen and 6 beta-hydroxypregnanolone excretions have been determined in female marmosets by means of HPTLC. The levels observed in cycling females during implantation and abortion are reported. Hormone analysis revealed a characteristic pattern showing cyclic fluctuations of estrogens and progesterone. Estrogen metabolites increase during the follicular phase up to 1 microgram/ml, the progesterone metabolite level rises to 1.2 micrograms/ml urine during the luteal phase. Maximum values of both are superimposed in many cases. Ovulatory cycles can be monitored by following estrogen and progesterone metabolites in urine samples. Thus ovulation and the onset of pregnancy can be estimated with a precision of +/- 24 h (or less).

17-alpha-Hydroxypregnenolone↗
PubMed1987

The prediction of ovulation and monitoring of the fertile period.

Simple and reliable methods have been sought for both predicting and confirming ovulation. Application of these methods could include management of infertile couples to aid in conception and for increasing the reliability of natural family planning (NFP) as a method of birth control. With the advent of specific hormone assays, serial measurements of estrogens, progesterone (and metabolites), and luteinizing hormone have been the gold standard of monitoring ovarian function in women. However, newer and simpler methodologies have been described and are currently either in use or being tested. These include the measurement of basal body temperature (BBT), the evaluation of the volume, consistency and electro-conductivity of cervicovaginal fluid, salivary steroid content and cellular enzymatic activity, the use of enzyme-linked immunosorbent assays applied to solid-phase formats, and the investigation of new hormonal molecules as markers of reproductive state and function. These new technologies are described herein and their potential for monitoring ovarian function is discussed.

Body Temperature↗
PubMed1996

Calendar rhythm efficacy: a review.

OBJECTIVE: To estimate the unplanned pregnancy rate of calendar rhythm. DESIGN: Meta-analysis of eight studies of calendar rhythm published between 1940 and 1989. RESULTS: There exist few studies of the calendar rhythm method. Analysis of the best of these studies resulted in a conservative estimated Pearl rate of 18.5 +/- 1.8, and a less conservative estimate of 15.0 +/- 4.0, standardized to 12 months' observation; these results are in the range of other natural and barrier methods. DISCUSSION: We need properly done clinical trials of the calendar rhythm method to scientifically establish its effectiveness.

Female↗
PubMed1994

Billings natural family planning in Shanghai, China.

With cervical mucus, or Billings, method of family planning, a woman learns to recognize the characteristics of her cervical mucus that identify the fertile phase in her menstrual cycle. She and her partner abstain from sexual activity during a period from the first indication of mucus until four days after the mucus peak day, which includes ovulation. They also abstain during menses, because mucus can be confused with menstrual bleeding. This method of family planning is used widely, worldwide, by couples seeking a natural, reliable method of family planning. Between July 1988 and May 1990, 688 couples of child-bearing age, most of whom were parous, used the Billings method for contraception. Five hundred and fifty of these couples used the method for more than 12 months. Efficacy, continuation rates, and discontinuation rates were analyzed using life-table analysis for 10,175 woman-months of data collected. The net cumulative discontinuation rates per 100 women at 12 and 18 months were 19.85 and 34.58, respectively, resulting in continuation rates of 80.15 and 65.42. The discontinuation rates per 100 women for method-related reasons at 12 and 18 months were 1.61 and 2.84, respectively, while the discontinuation rates for unintended pregnancy were 1.02 and 1.18. During the study, 67 subjects volunteered to have vaginal smears taken from the upper part of the vaginal wall for cytologic examinations, and among them serum and urine LH levels were measured in 10 subjects and urinary estrogen and progesterone were assayed in 35 cases. These tests related other indications of the menstrual cycle to the ability of the women to judge ovulation by cervical mucus. Our research suggests that further investigation of the Billings method is warranted and that careful planning and organization are needed to disseminate the method more broadly.

Cervix Mucus↗