Return to fertility in nulliparous and parous women after removal of the GyneFix intrauterine contraceptive system.

OBJECTIVE: To evaluate the return to fertility following removal of the GyneFix intrauterine implant system in women wishing to conceive. STUDY DESIGN: A retrospective study was performed on a sample of healthy, sexually active nulligravid/nulliparous and parous women. The participants were 18-41 years of age, with no apparent infertility problem, living in a stable relationship and planning to become pregnant. Women who changed their mind and did not wish to become pregnant immediately after intrauterine device (IUD) removal were excluded from the study. Women were evaluated in terms of rates of conception and fertility outcome. A total of 128 women were evaluated. RESULTS: The study shows that 119 out of 128 (93%) past users of GyneFix have conceived, accounting for a net cumulative pregnancy rate of 88% at 12 months and 99% after 2 years' observation. No statistical differences in pregnancy rates were found for age and duration of use of the IUD. A strong significant difference in pregnancy rate was shown (p = 0.007) between parous and nulligravid/nulliparous women. Seventy-seven women (66.9%) gave birth to a term infant. There were no stillbirths. Twenty-five women (21.8%) are pregnant at the time of writing. Five (4.4%) spontaneous abortions occurred and in eight women (6.9%) the pregnancy was terminated. There were no ectopic pregnancies. CONCLUSION: The results obtained compare favorably with those obtained in previous studies conducted following the removal of copper IUDs. The use of the frameless IUD does not affect future fertility in nulligravid/nulliparous and parous women wishing to become pregnant following removal of the device. Nulliparous women conceive significantly earlier than parous women.

Randomized comparative trial in parous women of the frameless GyneFix and the TCu380A intrauterine devices: long-term experience in a Chinese family planning clinic.

OBJECTIVE: To compare the clinical performance of two intrauterine devices (the frameless GyneFix intrauterine device (IUD) and the TCu380A IUD) during long-term use. STUDY DESIGN: This was a randomized comparative study. A total of 157 insertions of the GyneFix IUD were compared with 156 insertions of the TCu380A IUD in the Tianjin Municipal Institute for Family Planning, China. Only parous women were included in the study. Insertions were conducted by the first three authors. The trial extended over a 9-year period, with over 10,000 woman-months of experience. RESULTS: The study showed that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0), compared to one pregnancy with the TCu380A IUD (cumulative pregnancy rate 0.64). The cumulative expulsion rate with the GyneFix IUD was 1.91 (three expulsions occurred, two of which were during the first 6 months), compared to a cumulative expulsion rate of 5.13 (eight expulsions) with the TCu380A (p = 0.1112). The total use-related discontinuation rate (terminations were mainly due to bleeding disturbances) was significantly lower (p = 0.0051) with the GyneFix IUD (4.46) than with the TCu380A IUD (14.10) and resulted in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (92.36 versus 83.97). Neither perforations nor cases of pelvic inflammatory disease were encountered with either device in this study, demonstrating the safety of the anchoring system. CONCLUSION: The results of the present clinical trial are in agreement with the findings of other multicenter, randomized, comparative, clinical trials that have investigated these two IUDs in China, as well as with the findings of other large-scale international studies conducted with the frameless IUD.

Immediate post-abortal insertion of the frameless GyneFix IUD: initial experience in China.

The promising results obtained with the frameless GyneFix IUD for interval insertion led to the belief that the technology could be useful for immediate post-abortal application to reduce the number of induced and repeat abortions. IUDs have many advantages and the method is acceptable and safe. However, side effects and expulsion of conventional IUDs remain a problem. In an attempt to minimise these problems, the frameless GyneFix IUD was developed. Clinical studies conducted over the past 14 years have shown that the principles on which the device is based are valid. An increasing bulk of clinical evidence shows that the design characteristics of the device (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness, and high tolerance and continuation rates.1 Experience with the frameless IUD in China since 1989 confirms the international experience with the device. The present communication is a second report from China with the GyneFix IUD. In the present study the GyneFix IUD is inserted immediately following termination of pregnancy of less than 10 weeks amenorrhea. It is concluded that immediate post-abortal insertion of the frameless IUD is easy and safe, and appears to be as reliable and as effective as when it is inserted at interval. The GyneFix IUD could, therefore, constitute an important new option in the prevention of abortion.

Intrauterine contraception in the year 2001: can intrauterine device use be revived with new improved contraceptive technology?

Intrauterine contraception is the most cost-effective reversible method of contraception today. The method is becoming increasingly attractive to women due to the development of new technologies that not only enhance the performance of the intrauterine device (i.e. efficacy is now close to 100%), but also reduce the rate of expulsion (in the case of the 'frameless' GyneFix intrauterine device (IUD)) and the number of removals for medical reasons. This is important, since the demand for intrauterine devices is likely to increase drastically in the coming years. The size of the intrauterine foreign body with the mini GyneFix has been reduced six-fold since the development of the Lippes Loop, resulting in an almost total absence of incompatibility problems. Furthermore, intrauterine contraception is entering a new phase with the development of intrauterine systems (IUSs) that deliver potent progestins. The Mirena intrauterine system, which releases levonorgestrel, has been shown to drastically reduce menstrual bleeding. The FibroPlant levonorgestrel IUS has been clinically developed since 1997 and is a further development of the 'frameless' anchoring IUD concept. The majority of women presenting with excessive bleeding can be treated by insertion of the IUS, resulting in greatly reduced menstrual blood loss. This is a very important result from both a health and a quality-of-life point of view. The fact that the IUS is also a potent contraceptive is extremely interesting. We believe, therefore, that these new technologies will lead to a re-appraisal of the IUD and could revive the use of intrauterine contraception in all parts of the world, including those regions where IUD use is presently very low.

Performance of the frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women.

The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was significantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD. Both Frameless IUD and TCu380A are highly effective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is significantly more effective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.

Intrauterine contraception in adolescent women. The GyneFix intrauterine implant.

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

The GyneFix implant systems for interval, postabortal and postpartum contraception: a significant advance in long-term reversible contraception. International Study Group on Intrauterine Drug Delivery.

Intrauterine contraception has a number of important advantages over other forms of contraception and remains, therefore, an important method of birth control. However, side-effects and other drawbacks have reduced its overall acceptance. Also misconceptions and lack of updated scientific knowledge among the potential users and providers are major obstacles to the widespread use of intrauterine contraception. Ideally, an intrauterine device (IUD) should prevent pregnancy effectively, be well tolerated, not become displaced or expelled over time, cause a minimum of side-effects, be long-lasting, have a strictly local effect, and be easy to insert and remove. A group at the University of Ghent, Belgium, the International Study Group on Intrauterine Drug Delivery, has developed, since 1985, a totally new concept in order to improve current intrauterine contraceptive efficacy and enhance tolerance, by creating a harmonious relationship between the uterine cavity and the contraceptive 'foreign body'. The new concept (GyneFix) consists of a non-biodegradable suture thread made of surgical 00 monofilament polypropylene on which six copper tubes are threaded, providing a total surface area of 330 mm2. The upper and lower tubes are crimped onto the thread to keep the tubes in place. The upper extremity of the thread is provided with a knot which serves as an anchor. The knot is implanted in the myometrium of the uterine fundus with a specially designed insertion instrument, thereby permanently securing the device in the uterine cavity. Since the initial clinical investigations, over 10,000 woman years of experience and up to 10 years' follow-up in international multicenter, non-comparative and comparative clinical trials have been collected. The clinical material also included a large number of nulligravid and nulliparous women. Due to the design characteristics of the GyneFix and its anchoring in the uterine fundus, an optimal tolerance and almost complete absence of expulsion were obtained. The constant release of copper ions in the upper part of the uterine cavity results in the high effectiveness of the anchored device. The effectiveness is higher than in the high-load conventional copper IUDs which have a risk of becoming displaced, partially or totally expelled in 10% or more (nulliparous women), resulting in a significant number of accidental pregnancies. The absence of frame and, as a consequence, its flexibility, explain the low incidence of side-effects and the very low incidence of complications, such as pelvic inflammatory disease and ectopic pregnancies. This new concept could be a major step forward in the acceptance of intrauterine contraception worldwide and increase its popularity. This article reviews the experience with the new concept for interval, postabortal and postpartum contraception.

[Intrauterine copper contraceptive implants]. / Implant intra-utérin contraceptif au cuivre (ICIU).

GyneFix, conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 women years of experience and up to 8 years of follow-up in international, multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. The following conclusions were reached: 1. The unique design characteristics of GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. GyneFix reduces the IUD-failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. 2. Frameless and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. 3. Insertion of GyneFix, with or without local anaesthesia, is easily accomplished in the office of a few minutes. Removal is easy, quick and painless. 4. GyneFix is an equally effective and well accepted method fro nulliparous women.

Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 postpartum intrauterine contraceptive devices: randomized study.

OBJECTIVE: The purpose of the investigation was to compare the 1-year expulsion and efficacy rates of the GYNE-T 380 and the GYNE-T 380 Postpartum intrauterine contraceptive devices when inserted within 10 minutes after expulsion of the placenta in a term pregnancy. The two intrauterine contraceptive devices were identical, except that one was inserted by means of a temporary fundal suspension system and the other was placed directly into the uterine cavity. STUDY DESIGN: The study was a multicenter, randomized trial of intrauterine contraceptive devices in which 300 subjects accepted the GYNE-T 380 IUD and 292 subjects the GYNE-T 380 Postpartum IUD in clinics with adequate follow-up. RESULTS: At 1 year the gross cumulative expulsion rate was 13.2 per 100 cases (39 expulsions) with the GYNE-T 380 intrauterine contraceptive device and 16.2 per 100 cases (46 expulsions) with the GYNE-T 380 Postpartum device. There was no significant difference in the rate of expulsion between the two devices at any time during the year. There was one first-year intrauterine pregnancy, which occurred in a subject using the GYNE-T 380 device. The continuation rate for each device was above 80 per 100. CONCLUSION: The results indicate that both the GYNE-T 380 Postpartum and the standard GYNE-T 380 intrauterine contraceptive devices are safe and effective when inserted immediately after delivery of the placenta.

PIP: In clinics in Belgium, Chile, and the Philippines, data on 300 healthy, sexually active acceptors of the GYNE- T 380 IUD were compared with data on 292 healthy, sexually active acceptors of the GYNE-T 380 Postpartum IUD in order to compare the 10-year expulsion and efficacy rates of these 2 IUDs when inserted within 10 minutes of delivery of the placenta in a term pregnancy. The IUDs were identical, except that the GYNE-T 380 Postpartum IUD was inserted by a temporary fundal suspension system, while the GYNE-T 380 IUD was inserted directly into the uterus. No perforations occurred. The minimal complications that did occur were the same as those associated with interval IUD insertion: irregular spotting, menorrhagia, and uterine cramping. The rates for IUD discontinuation due to bleeding or pain and for other medical reasons were the same for both copper- releasing IUDs (3%). The removal rate for other medical reasons was less than 1% for each IUD. The only intrauterine pregnancy occurred in a woman using the nonsuspended, standard GYNE-T 380 IUD. The IUD continuation rate was greater than 80% for each IUD. Within each clinic, no statistically significant difference in the IUD expulsion rate existed at any time during the 12-month study period. Overall, the expulsion rates for the 2 IUDs were similar (e.g., at 12 months, 16.2% for GYNE-T 380 Postpartum IUD and 13.2% for GYNE-T 380 IUD). The Philippine clinic had significantly higher 1-year IUD expulsion rates regardless of IUD type than the Chilean clinic (24-32% vs. 5-6%). The Belgian clinic had moderately high 1-year IUD expulsion rates regardless of IUD type (8-16%). The different expulsion rates between clinics suggest differences in techniques used during insertion. These findings show that both IUD types inserted immediately after placental delivery are safe and acceptable. If the techniques associated with the low expulsion rates in Chile can be taught, these IUDs can be a practical, safe, convenient, and acceptable contraceptive method.

Early occurrence of acute fatty liver in pregnancy.

We report a case of acute fatty liver of pregnancy characterized by its early occurrence in the 26th wk of a twin pregnancy. Usually, this illness begins only late in the third trimester, although onset of disease as early as 26 wk has already been reported. The death of both fetuses also illustrates the high mortality rate and the necessity for prompt diagnosis and treatment.

A randomized comparative study of the TCu380A and Cu-Safe 300 IUDs.

The Cu-Safe 300 is one of the latest additions to the array of available IUDs. It was specifically designed to decrease unwanted side-effects (e.g. bleeding, pain and expulsion) while providing simplicity of insertion, ease of removal and fair contraceptive protection. For comparison, the TCu380A was chosen. Both types were inserted at random in 600 recipients by a group of independent physicians with a long standing experience in intrauterine contraception. Life table analysis was used for comparison over a period of three years. The Cu-Safe 300 produced a slightly but not statistically significant higher pregnancy rate and more expulsions. Removals for bleeding and pain, however, were significantly less frequent. All inserting physicians agreed that insertion and removal of this new device was remarkably easy.

The frameless GyneFix intrauterine implant: a major improvement in efficacy, expulsion and tolerance.

The CuFix (GyneFix), conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 woman years of experience and up to 8 years of follow-up in international multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached: The unique design characteristics of the GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. The GyneFix reduces the IUD failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. Framelessness and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.

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.

Aminoterminal propeptide of type III procollagen in cord blood and amniotic fluid of high-risk pregnancies: a biochemical approach to the dynamic assessment of deviant fetal growth.

N-terminal propeptide of type III procollagen (PIIINP) concentration was measured in cord serum, amniotic fluid, and maternal serum from high-risk pregnancies. The fetal PIIINP variability was shown to be independent of the maternal serum PIIINP values. Although a highly significant negative correlation was found between the fetal propeptide level and gestational age in both appropriate-for-gestational-age neonates (n = 504) and small-for-gestational-age infants (n = 98), the PIIINP concentration in cord serum or amniotic fluid of small-for-gestational-age infants was significantly lower compared with that of appropriate-for-gestational-age infants matched for postconceptional age. PIIINP assay may thus serve as a dynamic biochemical indicator of deviant fetal growth. The PIIINP results were also related to the severity or duration of intrauterine growth retardation, as indicated by significantly lower propeptide cord serum values in nonmalformed small-for-gestational-age infants with small head circumference, known as an index for the chronicity of fetal nutritional deprivation. Preeclampsia, maternal diabetes or smoking, and congenital anomalies appeared not to be associated with any alteration of fetal propeptide concentration, provided they did not cause fetal growth deceleration. The finding of extremely high cord serum PIIINP values in six newborn infants with the Potter malformation sequence led to the speculation that large amounts of propeptides or their fragments usually are excreted by the fetal kidneys into the amniotic fluid. We suggest that determination of the PIIINP level in amniotic fluid or cord serum, obtained by amniocentesis and percutaneous umbilical sampling, may be a helpful adjunctive biochemical parameter in future research protocols assessing fetuses at risk for intrauterine growth retardation.

Immediate postplacental insertion and fixation of the CuFix postpartum implant system.

Since promising results were obtained with the CuFix interval implant system in international clinical trials conducted worldwide, a modification of the device adapting it for immediate postplacental insertion and fixation (IPPIF) seemed a logical approach to solve the expulsion problem of IUDs inserted at that particular time. Seventy-three insertions were performed at three university centers, during 1990 and 1991, both by skilled and unskilled investigators. The results of this multicenter study show the excellent retainability of the modified IUD supporting the validity of the anchoring principle. The insertion procedure is easy, requiring minimal training, and the insertion technique appeared to be safe.

PIP: Physicians inserted the CuFix postpartum (CuFixPP) implant system, an IUD, to a depth of 1.3 cm in the fundal myometrium in 73 healthy women soon after vaginal delivery (10-30 minutes) at either the University Hospital in Gent, Belgium; the University Medical School in Debrecen, Hungary; or Alexandra Hospital of the University of Athens in Greece. Since previous international clinical trials showed unacceptably high rates of expulsion of CuFixPP, researchers conducted this trial to test the IUD after having it modified for immediate postplacental insertion and fixation. None of the physicians had received training in the insertion procedure of this experimental IUD. The cumulative expulsion rate at 12 and 18 months was 3.1. The cumulative pregnancy rate at 12 and 18 months stood at 1.5. The sole reasons for removal at 12 and 18 months were bleeding/pain and planned pregnancy (7.4 at 12 and months and 10.8 at 18 months; 9 at 12 months and 12.2 at 18 months, respectively). Physicians experienced difficulty removing the IUD in 4 cases. The removals did not cause noticeable bleeding. No complications occurred. These findings revealed that, with further modifications, the CuFixPP IUD holds considerable promise as a simple and effective method of postpartum contraception, which can easily be inserted by nurses or midwives, especially in developing countries.

Perinatal manifestations of maternal yellow nail syndrome.

A term female firstborn infant had unexplained nonimmune fetal hydrops and recurrent left chylothorax at 4 weeks of age. A few months before conception, her mother had had acute dystrophic nail changes and is being treated for recurrent sinusitis, bronchiectasis, and a deficiency of serum IgG2. We suggest that they both suffer from a dominantly inherited congenital lymphedema syndrome known as 'yellow nail dystrophy.' Prenatal manifestation of this disorder has not been reported previously. The child's anthropometric and neurological development was normal at 1 year of age, whereas mild ankle edema and marbling of the skin of the limbs were salient clinical findings. Inherited lymphedema leading to nonimmune fetal hydrops also has been recognized in chromosomal disorders, Noonan's syndrome, multiple pterygium syndrome, pulmonary lymphangiectasis, and mixed-vessel lymphatic dysfunction. Indicators of parental lymphedema are not on record in those instances.

Clinical experience with the GYNE-T 380 postpartum intrauterine device.

OBJECTIVE: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions. DESIGN: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus. PATIENTS, PARTICIPANTS: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites. MAIN OUTCOME MEASURES: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively. RESULTS: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.

PIP: The insertion of conventional IUDs during the 1st 10 days after delivery is associated with a high rate of expulsions. The Gyne T 380 (Ortho Pharmaceutical, Canada Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no.2 catgut to the top of the IUD (Gyne T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the of the uterine fundus. This modified IUD was evaluated in a phase II trial involving 190 women at 4 clinical sites; continuation rate was 74/100 women, the life table expulsion rate as 9.6 and 13.3/100 women observed at 6 and 12 months, respectively. There were no pregnancies during the 1st year of study. Complications associated with the insertion and use of this IUD were minimal and largescale trials evaluating this IUD are now in progress.

Gestodene: clinical experience with an innovative progestogen used in a combination oral contraceptive preparation.

The contraceptive efficacy, tolerance, and safety of a new monophasic oral contraceptive that combines 75 mcg gestodene (delta-15- levonorgestrel) and 30 mcg ethinyl estradiol were studied in 75 women (944 cycles) currently at risk for pregnancy. 20 women were nulliparous. No woman became pregnant during the trial, nor were vital signs of body weight affected by the drug. Cycle control was excellent, with no bleeding irregularities in 92% of the cycles. Serious complications did not occur. The low incidence of side effects, e.g. headache (9%) and breast tenderness (8%), indicated that the gestodene combination was well-tolerated. In a subgroup of 10 women, no changes in routine laboratory tests could be demonstrated after 12 cycles of treatment.

Long-term experience with Multiload intrauterine devices.

This paper reports the joint experience of three investigators who used three types of the Multiload (ML) IUD (MLCu250 Short, MLCu250 Standard, and MLCu375) in 1987 consecutive insertions during which an experience of 56,005 woman-months of use was accumulated. The material was analyzed using the life-table method and complemented with a case by case investigation, the main purpose of the study being the specific analysis of IUD-related complications. The authors also evaluated return of fertility whenever a device was removed because of wish of pregnancy. Results indicate that serious IUD-related complications were rare, continuation rate high, and reversibility of fertility unaffected by the device.