Natural conception rates in subfertile couples following fertility awareness training.

PURPOSE: To analyze cumulative pregnancy rates of subfertile couples after fertility awareness training. METHODS: A prospective observational cohort study followed 187 subfertile women, who had received training in self-observation of the fertile phase of the menstrual cycle with the Sensiplan method, for 8 months. The women, aged 21-47 years, had attempted to become pregnant for 3.5 years on average (range 1-8 years) before study entry. Amenorrhea, known tubal occlusion and severe male factor had been excluded. An additional seven women, who had initially been recruited, became pregnant during the cycle immediately prior to Sensiplan training: this is taken to be the spontaneous pregnancy rate per cycle in the cohort in the absence of fertility awareness training. RESULTS: The cumulative pregnancy rate of subfertile couples after fertility awareness training was 38% (95% CI 27-49%; 58 pregnancies) after eight observation months, which is significantly higher than the estimated basic pregnancy rate of 21.6% in untrained couples in the same cohort. For couples who had been seeking to become pregnant for 1-2 years, the pregnancy rate increased to 56% after 8 months. A female age above 35 (cumulative pregnancy rate 25%, p = 0.06), couples who had attempted to become pregnant for more than 2 years (cumulative pregnancy rate 17%, p < 0.01), all significantly reduce the chances of conceiving naturally at some point. CONCLUSIONS: Training women to identify their fertile window in the menstrual cycle seems to be a reasonable first-line therapy in the management of subfertility.

The effectiveness of a fertility awareness based method to avoid pregnancy in relation to a couple's sexual behaviour during the fertile time: a prospective longitudinal study.

BACKGROUND: The efficacy of fertility awareness based (FAB) methods of family planning is critically reviewed. The objective was to investigate the efficacy and the acceptability of the symptothermal method (STM), an FAB method that uses two indicators of fertility, temperature and cervical secretions observation. This paper will recommend a more suitable approach to measure the efficacy. METHODS: Since 1985, an ongoing prospective observational longitudinal cohort study has been conducted in Germany. Women are asked to submit their menstrual cycle charts that record daily basal body temperature, cervical secretion observations and sexual behaviour. A cohort of 900 women contributed 17,638 cycles that met the inclusion criteria for the effectiveness study. The overall rates of unintended pregnancies and dropout rates have been estimated with survival curves according to the Kaplan-Meier method. In order to estimate the true method effectiveness, the pregnancy rates have been calculated in relation to sexual behaviour using the 'perfect/imperfect-use' model of Trussell and Grummer-Strawn. RESULTS: After 13 cycles, 1.8 per 100 women of the cohort experienced an unintended pregnancy; 9.2 per 100 women dropped out because of dissatisfaction with the method; the pregnancy rate was 0.6 per 100 women and per 13 cycles when there was no unprotected intercourse in the fertile time. CONCLUSIONS: The STM is a highly effective family planning method, provided the appropriate guidelines are consistently adhered to.

Determination of the fertile window: reproductive competence of women--European cycle databases.

OBJECTIVES: The objective of the present paper is to review the main results of recent European cycle databases on ovulation detection and determination of the fertile window performed by the women themselves. METHODS: The ongoing German Long-term Cycle Database currently comprises 32788 prospectively collected cycle charts of 1551 women, the I European Cycle Database (10 countries) 1328 women/19048 cycles, the II European Cycle Database (six countries) 782 women/6724 cycles, and the World Health Organization Database (one European country) 234 women/2808 cycles. The women record cycle parameters (cervical mucus changes, temperature rise, etc.), family planning intention and sexual behavior. RESULTS: With the symptothermal method of natural family planning it has become possible to determine the fertile window in order to avoid pregnancy with a method effectiveness of 0.3%. According to a small sub-study, the ovulation time observed by the women themselves correlates closely with ovulation detected by ultrasound and measurement of luteinizing hormone (correlation within 1 day in 89% of the 62 cycles). Fertility awareness methods can be integrated into the management of sub-fertility. They seem to shorten the time to pregnancy. CONCLUSIONS: Self-observation of the fertile window puts women into a position to develop a high level of reproductive competence that could be used much more in different areas than is currently the case.

Definition and prevalence of subfertility and infertility.

A common definition of sub- and infertility is very important for the appropriate management of infertility. Subfertility generally describes any form of reduced fertility with prolonged time of unwanted non-conception. Infertility may be used synonymously with sterility with only sporadically occurring spontaneous pregnancies. The major factor affecting the individual spontaneous pregnancy prospect is the time of unwanted non-conception which determines the grading of subfertility. Most of the pregnancies occur in the first six cycles with intercourse in the fertile phase (80%). After that, serious subfertility must be assumed in every second couple (10%) although--after 12 unsuccessful cycles--untreated live birth rates among them will reach nearly 55% in the next 36 months. Thereafter (48 months), approximately 5% of the couples are definitive infertile with a nearly zero chance of becoming spontaneously pregnant in the future. With age, cumulative probabilities of conception decline because heterogeneity in fecundity increases due to a higher proportion of infertile couples. In truly fertile couples cumulative probabilities of conception are probably age independent. Under appropriate circumstances a basic infertility work-up after six unsuccessful cycles with fertility-focused intercourse will identify couples with significant infertility problems to avoid both infertility under- and over-treatment, regardless of age: Couples with a reasonably good prognosis (e.g. unexplained infertility) may be encouraged to wait because even with treatment they do not have a better chance of conceiving. The others may benefit from an early resort to assisted reproduction treatment.

Estimated maximum failure rates of cycle monitors using daily conception probabilities in the menstrual cycle.

BACKGROUND: A number of menstrual cycle monitors have been developed to detect the fertile window of the menstrual cycle, mainly for contraceptive purposes. Reliable data on most of these systems are still missing but are urgently needed because many women use them and the tested systems differ enormously in price and effectiveness. We suggest a new efficacy estimating method to evaluate cycle monitors prior to full prospective clinical trials. METHODS: Sixty-two women prospectively tested seven cycle monitors and the symptothermal method (STM) of natural family planning (NFP) but not more than two different systems at the same time. The clinical fertile window was determined by detecting the day of ovulation using daily urinary LH measurements and daily ultrasonic folliculometry. This was compared to the fertile phase predicted by the systems. Maximum failure rates were estimated for each cycle monitor and the STM, using the daily conception probability rates taken from the European Fecundability Study. Intercourse was assumed to occur on each of all falsely predicted days of infertility. RESULTS: Sixty-two women with a mean age of 31 years (range: 21-42 years) contributed a total of 122 cycles to this study. Monitors based on the microscopic evaluation of saliva or mucus had many more false infertile days than the other methods based on temperature or hormonal measurements (225 versus 42 days). The maximum unintended pregnancy rates per cycle for temperature computers were estimated to be 0.0134-0.0336, for the hormonal computer 0.1155 and for mini-microscopes 0.2313-0.2369. For the STM of NFP, there were no false infertile days. CONCLUSIONS: The STM of NFP proved to be the most effective contraceptive method to detect the fertile window among all the methods tested. The estimated efficacy of the other cycle monitors range from the temperature computers (upper level) to the hormonal computer (medium level) and the mini-microscopes with very low estimated contraceptive efficacy.

Time to pregnancy: results of the German prospective study and impact on the management of infertility.

BACKGROUND: The likelihood of spontaneous conception in subsequent cycles is important for a balanced management of infertility. Previous studies on time to pregnancy are mostly retrospective and biased because of exclusion of truly infertile couples. The study aim was to present a non-parametric estimation of cumulative probabilities of conception (CPC) in natural family planning (NFP) users illustrating an ideal of human fertility potential. METHODS: A total of 346 women was observed who used NFP methods to conceive from their first cycle onwards. The couples practising NFP make optimal use of their fertility potential by timed intercourse. The CPC were estimated for the total group and for couples who finally conceived by calculating Kaplan-Meier survival rates. RESULTS: A total of 310 pregnancies occurred among the 346 women; the remaining 36 women (10.4%) did not conceive. Estimated CPC for the total group (n = 340 women) at one, three, six and 12 cycle(s) were 38, 68, 81 and 92% respectively. For those who finally conceived (truly fertile couples, n = 304 women), the respective pregnancy rates were 42, 75, 88 and 98% respectively. Although the numbers of couples in both groups were similar, the impact of age on time to conception, as judged by the Wilcoxon test, was less in the truly fertile than in the total group. CONCLUSIONS: Most couples conceive within six cycles with timed intercourse. Thereafter, every second couple is probably either subfertile or infertile. CPC decline with age because heterogeneity in fecundity increases. In the subgroup of truly fertile couples, an age-dependent decline in CPC is statistically less obvious because of high homogeneity, even with advancing age.

Cycle characteristics after discontinuation of oral contraceptives.

Nearly 60% of the women between 20 and 40 years of age who do not want to conceive choose oral contraceptives (OCs) for contraception in Germany. In an ongoing prospective study on the use of natural family planning in Germany, 175 women have been observed for 3,048 cycles immediately after having discontinued OCs (post-pill group). They were compared to a control group of 284 women observed for 6,251 cycles, who had never taken OCs. Both groups were comparable in age and sociodemographic characteristics. After discontinuing OCs, 57.9% of all first cycles were ovulatory with sufficient luteal phases. However, for the total post-pill group the cycle length was significantly prolonged up to the ninth cycle. A significantly higher number of luteal phases were insufficient in the post-pill group. Major cycle disturbances (cycle length > 35 days or luteal phase of < 10 days of elevated basal body temperature or anovulatory cycles) were significantly more frequent in the post-pill group up to the seventh cycle. Cycle disturbances after discontinuing OCs were reversible but the time of regeneration took up to 9 months (significant) or even longer (not significant). These results will help to counsel couples who wish to conceive after discontinuing OCs or who want to continue contraception with alternative methods.

Personal hormone monitoring for contraception.

OBJECTIVE: To determine the effectiveness and acceptability of personal hormone monitoring for contraception. DESIGN: A large prospective study was carried out on personal hormone monitoring for contraception when used with abstinence during the identified fertile days. SETTING: Three country study under the auspices of the departments of Obstetrics and Gynaecology of the Universities of Birmingham, Dublin and Dusseldorf SUBJECTS: Seven hundred and ten women, median age 30, were recruited from the general population. They were required to have regular menstrual cycles (23-35 days) and to be delaying their next pregnancy. INTERVENTIONS: Personal hormone monitoring consists of a hand held monitor and disposable test sticks which measure changes in urinary concentrations of oestrone-3-glucuronide and luteinising hormone. An algorithm estimated the fertile days which were displayed by a red light. OUTCOME MEASURES AND RESULTS: One hundred and sixty two pregnancies occurred in 7209 cycles of use, of which 67 were method related pregnancies. The 13 cycle life-table method pregnancy rate (95 per cent CI) was 12. 1 per cent (9.3-14.8). The system allowed analysis of the effect of changes to the algorithm to modify the defined fertile period. As a result the algorithm was changed to increase the median warning of the luteinising hormone surge to six days. With the revised algorithm, half of the method pregnancies would have been prevented giving a calculated method pregnancy rate of 6.2 per cent (4.2-8.3) and method efficacy of 93.8 per cent. The continuation rate after 13 cycles was 78 per cent. CONCLUSION: Personal hormone monitoring proved simple to use and will be of value to women who do not want to use other methods of contraception.

PIP: A newly developed personal system of hormone monitoring allows the rapid assay of estrone-3-glucuronide (EG) and luteinizing hormone (LH) in urine to determine the fertile period. The Persona system consists of disposable test sticks to measure EG and LH concentrations in early morning urine and a hand-held monitor that indicates by the use of red and green lights the fertile and infertile phases of the cycle. The monitor stores information for the previous 6 cycles and adapts to the individual user's patterns. The effectiveness of this regimen when used with abstinence during the identified fertile period was investigated in a prospective population-based study conducted in the UK, Ireland, and Germany. 710 women (median age, 30 years) with regular menstrual cycles were enrolled. The continuation rate after 13 cycles was 78%. 162 pregnancies occurred in 7209 cycles of use, 67 of which were method-related. The 13-cycle life-table method pregnancy rate was 12.1% (95% confidence interval (CI), 9.3-14.8%). As a result of these findings, the algorithm was changed to increase the median warning of the LH surge from 4 to 6 days. Had this revised algorithm been used, the method pregnancy rate would have been reduced to 6.2% (95% CI, 4.2-8.3%) and method efficacy increased to 93.8%. The total efficacy rate compares favorably with pregnancy rates in women using other nonhormonal methods of fertility control. Women with cycle lengths of 23-35 days can expect to be required to abstain from intercourse for 6-12 days each cycle.

Research and quality control in natural family planning with relational database systems.

Research and quality control in natural family planning (NFP) is based on continuous data collection in prospective studies. The quality of the data is determined by the reliability of collection, input, management, and retrieval. During a period of ten years, different relational databases were programmed to manage the large number of very different data in NFP studies. Recently, all experience with different database systems has been summarized by writing and testing a completely new data management system based on MS Access 97: NFPDAT 1.0. This new software is used for data collection, evaluation and administration in NFP Study Groups. Over 200 internal formulae guarantee maximum data consistency while 30,000 cycles from 1477 patients were stored. Easy data evaluation for research and administration is possible with the help of a new report generator even without prior knowledge of SQL (System Query Language) or Visual Basic for MS Access 97. Using this method, interim results for research and quality control can be obtained at any time. NFPDAT can be used by all Natural Family Planning Study Groups using the symptothermal method for research and administration. With the help of NFPDAT, various prospective studies of Natural Family Planning were conducted.

Effects of add-back therapy on bone mineral density and pyridinium crosslinks in patients with endometriosis treated with gonadotropin-releasing hormone agonists.

Treatment of endometriosis with gonadotropin-releasing hormone agonists (GnRHa) is limited to 6 months because of possible adverse effects on bone metabolism. We designed a randomized, double-blind, placebo-controlled, prospective study of 27 patients with endometriosis who were given GnRHa with or without hormone add-back therapy (+ 20 microg of ethinyl estradiol with 0.15 mg desogestrel) designed to suppress the adverse effects of hypoestrogenism while preserving the efficacy of GnRHa. Both regimens showed significant improvements in endometriosis, dysmenorrhea, and pelvic pain; effects were significantly better in the GnRHa + placebo group. The GnRHa + placebo group had significantly higher serum calcium levels and a significantly higher loss of lumbar spine bone mineral density (BMD). Urinary levels of pyridinium crosslinks increased significantly in the GnRHa + placebo group, and declined to normal in the GnRHa + add-back group. The add-back therapy protects women taking GnRHas from severe loss of BMD and accelerated bone collagen resorption, but reduces the efficacy of the GnRHa.

Retrospective clinical trial of contraceptive effectiveness of the electronic fertility indicator Ladycomp/Babycomp.

The Babycomp/Ladycomp (Valley Electronics Ltd., Eschenlohe, Germany) is an electronic device that combines the temperature method and calendar method for planning and preventing pregnancy by identifying the fertile and infertile phases of the menstrual cycle. In a retrospective clinical trial, the system was tested as a contraceptive aid. A total of 648 women from Germany and Switzerland have participated: 597 women with 10,275 months of use used the device for contraception. Thirty-three unplanned pregnancies were identified, giving a total pregnancy rate of 3.8 use effectiveness according to the Pearl Index. Six method-related pregnancies occurred, producing a method Pearl Index of 0.7. Calculating the cumulative pregnancy rates by life-table analysis, it was found that, after about one year of exposure, the probability of an unintended pregnancy was 5.3% (0.053), after 2 years it was 6.8% (0.068) and after about 3 years of exposure it was 8.2% (0.082). The mean length of the identified fertile period was 14.3 days with a standard deviation of 4.6 days in all cycles reported. The acceptance of the device by the woman and her partner was good. In fact, 21 of the 33 women who became pregnant would still recommend the device for further use (63.6%).

Steroidal 'add-back' therapy in patients treated with GnRH agonists.

GnRH analogues (GnRH-a) are well established in the treatment of endometriosis. However, due to hypooestrogenic effects, treatment is limited to 6 months. The aim of this randomized, double-blind, comparative study was to evaluate whether symptoms and signs of hypooestrogenism, e.g. hot flushes, sweating and sleeplessness, could be avoided by a steroidal add-back regimen, while the beneficial effect of a GnRH-a on endometriosis could be maintained. In group A, 14 patients were treated with 3.75 mg leuprorelin acetate depot per month i.m. in combination with 20 mg ethinyloestradiol plus 0.15 mg desogestrel orally for 3 weeks. In group P, 13 patients received leuprorelin acetate, following the same schedule as in group A, and placebo. Treatment duration was 6 months. At first-look laparoscopy (postoperatively) group A had an r-AFS score of 23.57 and group P of 24.23. After 6 months of treatment with leuprorelin acetate depot r-AFS scores had dropped to 16.14 in group A and to 6.25 in group P at second-look laparoscopy, achieving statistical significance in both groups (p < 0.001). Hypooestrogenic adverse drug reactions (e.g. hot flushes, sweating and sleeplessness) were more frequently reported in group P, whereas the occurrence of headache was comparable in both groups. Dysmenorrhoea was significantly reduced in both groups, whereas dyspareunia was only decreased in group P. Variations in laboratory values were within normal ranges and did not give any concern about drug safety. Loss of bone mineral density caused by the GnRH-a was reduced by the combined oestrogen/progestin add-back therapy. In conclusion, this therapy can lead to a reduction in hypooestrogenic adverse drug reactions and mostly preserves agonist efficacy with the chance of treatment prolongation.

Results of an efficacy-finding study (EFS) with the computer-thermometer Cyclotest 2 plus containing 207 cycles.

Prospectively collected cycles of 207 women were used to find out the efficacy of the Cyclotest 2 plus algorithm in detecting the fertile time in a woman's cycle. The results of the device were compared with the beginning and the end of the fertile time identified by the symptothermal method (STM) of natural family planning (NFP). It was found that the algorithm led to dangerous reduction of the fertile time (FT) in only 2 out of 207 woman cycles (0.96%). However, at the end of fertile time (FE) the device requested more abstinence than was necessary in about 12% of the cycles. We feel that more research should be performed on detecting the end of the fertile time.

Present stage of knowledge of reproductive biology concerning natural family planning.

PIP: "The common cycle length variation of the woman's cycle in a healthy population is five days.... We believe that the temperature shift in the middle of the cycle is caused by the peripheral effect of estradiol and progesterone on the peripheral circulation. The time from the beginning of the development of an individual spermatozoa to the appearance of a ripe spermatozoon in the ejaculate is about three months. The lifespan of the ripe oocyte is 18-24 hours. The duration of fertilizing capacity of sperm can be five days with decreasing probability; in very rare cases it can be seven days. The probability of conception in our very simple model was 33.3% at ovulation day (day 0)." (EXCERPT)^ieng

Natural family planning with and without barrier method use in the fertile phase: efficacy in relation to sexual behavior: a German prospective long-term study.

A large prospective long-term study with users of natural family planning (NFP) methods has been conducted to analyze the relation between unintended pregnancy rates and sexual behavior with special reference to barrier method use in the fertile phase. Seven hundred and fifty eight NFP beginners, 19-45 years of age, 14870 cycles, 28 unintended pregnancies were studied. Of the couples, 54.2% use NFP only or predominantly and 45.9% use mixed methods (additional barrier method use in the fertile phase in 55.7% of the cycles). The overall pregnancy rate after 12 cycles of exposure is 2.2% according to the actuarial method. There is no significant difference between NFP users and mixed methods users and also no significant effect of duration of use in the first 5 years of exposure. During "perfect use" the pregnancy rate at 12 months is 0.63%. When only protected intercourse takes place in the fertile phase the pregnancy rate is 0.45%. The symptothermal method of NFP is most unforgiving for imperfect use (unprotected intercourse in the fertile phase). However, it is extremely effective when either abstinence or protected intercourse is used in the fertile phase.

The CUE Fertility Monitor compared to ultrasound and LH peak measurements for fertile time ovulation detection.

A prospective study of the reliability of the CUE Fertility Monitor to identify the fertile time of the menstrual cycle was conducted. The device provides a digital measurement of the electrical resistance of saliva (SER) and vaginal secretions (VL). The readings of the device were compared with the fertile time detected by ultrasonography of the growing follicle and estimation of the LH surge to detect ovulation. Thirteen women participated in the study. Sixteen cycles contained both signals (SER, VL) for the beginning and the end of the fertile period. In 2 cycles a CUE signal could not be found by the device. Using a computerized algorithm for evaluation of the CUE signals, the beginning of the fertile period was accurately detected in 14 cycles; in 2 cycles the signal was found less than five days prior to ovulation. The last day of fertility was identified correctly by the CUE Fertility Monitor in 10 cycles; in 6 it was incorrectly identified during the time when the woman was still fertile. This suggests that the CUE Fertility Monitor utilizing the algorithm on which it currently is based cannot be recommended for natural family planning. However, we think that the algorithm for evaluation should be improved as useful signals in the menstrual cycle are detected.

[How do self-observed cycle symptoms correlate with ovulation?]. / Wie korrelieren selbstbeobachtete Zyklussymptome mit der Ovulation?

The symptoms of self-observation of the menstrual cycle (basal body temperature, mucus symptom, autopalpation of the cervix) are often regarded as not reliable for ovulation detection. In a prospective study 87 NFP cycles are monitored additionally with ultrasound and LH tests to calculate the correlation of the ovulation-time with the symptoms of self-observation. Our results show that the symptoms of self-observation allow a reliable detection of the time of ovulation. Only a short introduction into the method of self-observation is a necessary precondition. The reliable detection of ovulation gives the opportunity of cycle analysis of large groups especially in long time investigations. In this way a large set of valuable and reliable data on normal and disturbed menstrual cycles will be available.