István Batár

Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study

The use-effectiveness of an intrauterine contraceptive device releasing 20 mcg of levonorgestrel daily (Lng-IUD), and of a Nova T copper-releasing IUD, were studied in a randomized, comparative multicenter trial. The Lng-IUD was inserted in 1821, and the Nova T in 937 women. The 12-month net pregnancy rate with the Lng-IUD (0.1 per hundred women) was significantly lower than that with the Nova T (0.9 per hundred). Removal rates for menstrual problems and/or pain were similar for the two methods (net rates 7.5 and 8.7, respectively). The 12-month continuation rates were 82.2 for the Nova T and 79.7 for the Lng-IUD. The reduction of the bleeding led to oligomenorrhea and amenorrhea in users of the Lng-IUD; the removal rate for these reasons was 1.4. The removal rate for hormonal side effects with the Lng-IUD was 2.4. Blood hemoglobin concentrations increased among users of the Lng-IUD and decreased among users of the Nova T. The results show that the Lng-IUD was a highly effective contraceptive method which reduced menstrual bleeding. It is a promising alternative for women desiring a highly effective method for long-term use.

Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T

In a European randomized multicenter study, the efficacy and safety of an intrauterine contraceptive device releasing 20 microgram levonorgestrel/24 hours (LNG-IUD) have been evaluated and compared to the Nova-T. Because the LNG-IUD has a strongly suppressive effect on the endometrium and in some women affects ovarian function, the return to fertility after removal of the IUD was studied. Two-hundred-nine women (71 in the Nova-T and 138 in the LNG-IUD group), who had their IUDs removed because of planning pregnancy, were followed at least 24 months or until termination of pregnancy. For the Nova-T, the cumulative conception gross rate was 71.2/100 women after 12 months (79.7 after 24 months) and for the LNG-IUD 79.1 (86.6 after 24 months). The difference between the devices is not statistically significant, and in spite of the endometrial suppression during use of LNG-IUD, there is no delay of return to fertility and in both groups 96% of the pregnancies occurred during the first year after removal of the device. Eighty-four % of the pregnancies in the Nova-T group and eighty-six % in the LNG-IUD group ended in live births. The results suggest that the endometrium recovers quickly, normal ovulations are established and the fertility seems to be unaffected after use of an LNG-IUD.

State-of-the-art of non-hormonal methods of contraception: III. Intrauterine devices

Since the 1959 revival of the IUD, non-hormonal devices have become the most widely used of all reversible contraceptives. Pregnancy rates of copper-releasing IUDs in current use range from approximately 0.5 to 1.5 per hundred continuing users in the first year, with somewhat lower annual pregnancy rates thereafter. Evidence-based research has been systematically conducted and translated into guidelines for eligibility criteria and problem management. Recent device research, beyond the T, Multiload and frameless devices has centred on improved designs such as U ,Y and Slimline shapes, or enhanced copper release, the latter through electrochemical effects or nanotechnology applications. Other IUD research foci concern devices that decrease bleeding and pain by releasing non-steroidal anti-inflammatory drugs. Yet other research lines indicate noncontraceptive benefits of copper intrauterine devices in protecting against endometrial cancer, and favourable risk-benefit analyses of IUD use by women at risk of or post HIV infection. IUD mechanisms of action and the relation of IUDs to pelvic infection and ectopic pregnancy are briefly reviewed. For our literature search we used Medline, Popline and Cochrane Library data bases, Google search, our personal files, and the references contained in articles in our files.

The ‘frameless’ intrauterine system for long‐term, reversible contraception: A review of 15 years of clinical experience

Aim:  The development of the ‘frameless’ intrauterine system (IUS) is a response to the growing need to develop high‐performing, long‐acting, reversible, and acceptable contraceptives with a high continuation of use.

IUD expulsion solved with implant technology

In an attempt to minimize the problem of IUD expulsion, implantation technology has been developed and tested. The trials have extended from 1985 until the present time for interval as well as for immediate postabortal and post-placental insertion and fixation of the CuFix IUD (Gyne-Fix). The present article reports on an ongoing study with GyneFix interval insertion, with an improved inserter, in 820 women, observed up to 3 years, of whom 213 (25.9%) are nulligravid/nulliparous. The cumulative expulsion rate is 0.6 per 100 women-years at 3 years and is not significantly higher in the nulligravid/nulliparous group. The cumulative pregnancy rate is 0.6 and the cumulative removal rate for medical reasons 3.2 at 3 years. The total experience in this multicenter study covers approximately 14,000 woman-months. It is concluded that the design characteristics of the GyneFix (fixed, frameless, and flexible) explain the low expulsion, high efficacy and high acceptability rates. The implantation technology is very effective and the improved inserter allows easy insertion and optimal anchoring.

State-of-the-art of non-hormonal methods of contraception: IV. Natural family planning.

Despite the popularity of ‘modern’ contraceptives, natural family planning (NFP), including fertility awareness-based (FAB) methods and withdrawal, are practised in most countries. Worldwide FAB methods and withdrawal are used, respectively, by about 3.6% and 2.9% of all couples of reproductive age. This article describes the underpinnings of the different NFP methods, their rationales, histories, rules for use, efficacy and in broad categories their prevalence. Pregnancy rates of FAB methods with perfect use have ranged between 0.3 and 5.0 per 100 users per year, but typical use rates rises into the teens or higher. Withdrawal requires the male partner to be aware of his impending climax and to pull out of the vagina before ejaculation. Perfect use and typical pregnancy rates for withdrawal are estimated to be 4 and 27 per 100 per year, respectively. Many couples find NFP in accord with their own beliefs, satisfactory in its effectiveness and useful in planning a desired pregnancy. Many prize their self-control in practising NFP or withdrawal. In our research we used Medline, Popline and the Cochrane Library search engines in English, local institutional libraries, our own files in our native languages, the literature references contained therein, and source recommendations from colleagues.

So many years in the service of humanity - Egon Diczfalusy, homo universalis.

Egon Richard Diczfalusy was born in Miskolc, Hungary, on 19 September 1920. The family tree roots back to the Germany of the 16th century. His father, as well as his grandfather, served in the army. Since officers were often relocated, he attended primary and secondary schools in three different cities: Miskolc, Budapest, and Szeged. Some of these offered him the opportunity of learning languages such as English and Italian; the list of foreign languages he would master was later substantially extended. In 1938, the young high-school graduate gained admission to the Medical Faculty of Szeged University; he graduated ‘summa cum laude’, in 1944. Two years later, on the recommendation of the Hungarian Nobel-Prize laureate Albert Szent-Györgyi, he left for Sweden to work with that other Nobel-Prize winner, Hans von Euler-Chelpin, at the Institute of Organic Chemistry, University of Stockholm. He then joined the Hormone Laboratory headed by Axel Westman at the Department of Obstetrics and Gynaecology of the Karolinska University Hospital. In 1949 he became the head of the Hormone Laboratory. In acknowledgement of his achievements, and with Professor Westman’s support, the young immigrant researcher obtained Swedish citizenship in 1950. This was unusual at that time, as one normally had to wait for at least ten years to become a Swedish citizen. In 1953, Egon Diczfalusy defended his PhD thesis, and was appointed associate professor. The late 1950s and early 1960s brought greater scientific awards from the National Institute of Health (USA) and the Ford Foundation. Especially the latter enabled him to initiate a major research and training programme in human reproduction and fertility regulation. In 1967, he was appointed to the Swedish Medical Research Council as a special research professor, and, in 1970, eight years after receiving the grant from the Ford Foundation, the new ‘Karolinska Institutet’ was opened. The inauguration ceremony was attended by the director of the World Health Organisation, Figure 1 Professor Egon Diczfalusy giving his ‘valedictory lecture’, Szeged, October 2010.

State-of-the-art of non-hormonal methods of contraception: I. Mechanical barrier contraception.

Mechanical barriers, specifically male condoms, command renewed interest and are used today by more people. The worldwide prevalence rate of male condoms was about 6% in 2007 corresponding to 65 million cohabiting couples. The prevalence of female barrier methods, including diaphragms, cervical caps and female condoms has declined to less than 1% of women in North America and in north-west Europe. Even smaller percentages use female barriers elsewhere. First-year life table pregnancy probabilities of mechanical barrier methods range from 4 to 19 per hundred in clinical trials. The male condom is the only proved preventive tool against several sexually transmitted infections (STIs), especially HIV. The effectiveness of the diaphragm and cervical caps in this regard appears limited. Further research is needed to measure the efficacy of female condoms in disease prevention. Sponges are not known to protect against STIs. Because of their ease of use and availability, low short-term costs, relative freedom from side effects, and usefulness in combating STIs, mechanical barrier methods, especially condoms, will continue to be used on a large scale. For our literature search we used personal files, search engines such as Popline, Medline, PubMed and Google, and data bases of WHO, FHI and Cochrane Library.

Two-year clinical experience with Nova-T 380, a novel copper-silver IUD

In 1992, an open single-group phase III clinical trial was started at three centers to investigate the clinical performance of the high copper surface area Nova-T 380, a modification of Nova-T. This report presents the interim results of the first two years of use. A total of 400 women volunteers were enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minimum of 18 and a maximum of 44 years. At the cut-off date, 259 women had passed the 24-month visit. Gross cumulative life-table rates at the end of the first and second years, respectively, calculated by the Kaplan–Meier method, were as follows: pregnancy 0.5 and 1.6, expulsion 1.6 and 2.8, bleeding 4.7 and 8.7, pain 1.3 and 2.3, removal for other medical reasons 1.7 and 3.9, planning pregnancy 1.1 and 6.0, removal for other personal reasons 0.5 and 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continuation rates were 89.0 and 75.5 at 12 and 24 months, respectively. The first two-year performance of the Nova-T 380 was good. Bleeding problems were in the same range as with devices with smaller copper surface areas. No unexpected serious adverse events were encountered.

State-of-the-art of intrauterine contraception

Despite its nearly 100-year history, intrauterine contraception is a modern method even in the 21st century and its development is still going on. The aim of innovations is to optimize the contraceptive efficacy and to suppress as much as possible side effects and unwanted events (e.g. menstrual irregularities, expulsion). It is important that this method be made available to all those who could not resort to it earlier (young women, nulligravidae, nulliparae). Currently three areas are more particularly being investigated: (1) flexible, frameless intrauterine implants, (2) levonorgestrel-releasing intrauterine systems, and (3) metal alloy intrauterine devices. Partly relying on the authors own clinical experience and based on the literature of recent years, this article reviews the present state and possibilities with regard to further development of intrauterine contraceptive devices.