PubMed Health⌕ Search

Biomedical subjects

D Wildemeersch

Publications and source records attributed to D Wildemeersch.

At least 19 recordsLinked to original sources
PubMed2007

Endometrial safety after 5 years of continuous combined transdermal estrogen and intrauterine levonorgestrel delivery for postmenopausal hormone substitution.

OBJECTIVE: To investigate endometrial histology and thickness of the endometrium after long-term use of continuous transdermal estrogen substitution combined with intrauterine release of levonorgestrel (LNG) in postmenopausal women. DESIGN: A 5-year non-comparative prospective clinical trial. SUBJECTS: Out of 182 symptomatic postmenopausal women using estrogen substitution therapy (EST) combined with a novel T-shaped LNG-releasing intrauterine system (Femilis Slim LNG-IUS), to prevent endometrial proliferation and bleeding, only those women (n=102) who used two consecutive LNG-IUSs, were isolated with the aim to study the long-term effects on the endometrium. The mean age of the women was 57 years (range 47-71). The majority of women received percutaneous 17beta estradiol, 1.5mg daily, or an equivalent dose by patch or orally, on a continuous basis. MAIN OUTCOME MEASURES: Endometrial histology and ultrasonographic evidence of endometrial suppression, after a period of approximately 5 years of use. The mean duration of use of the regimen was 70 months (range 25-98). RESULTS: The dominant endometrial histologic picture was that of inactive endometrium characterized by glandular atrophy and stroma decidualization (Kurman classification 5b). No cases of endometrial hyperplasia were found. On transvaginal ultrasound, this corresponds with a thin endometrium (< or = 5 mm). CONCLUSION: The results of this 5-year study in 102 postmenopausal women using EST demonstrates that the LNG-IUS effectively opposes the estrogenic effect on the endometrium resulting in strong suppression during the entire period of EST. Due to its high efficacy and absence of systemic effects on organ tissues (e.g., breasts), target delivery in the uterine cavity could be a preferred route to administer a progestagen in women using EST.

Administration, Cutaneous↗
PubMed2004

Endometrial safety with a low-dose intrauterine levonorgestrel-releasing system after 3 years of estrogen substitution therapy.

OBJECTIVE: To evaluate the pharmacodynamic effects of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), on the endometrium in 24 postmenopausal women using estrogen substitution therapy (EST) to suppress climacteric symptoms. DESIGN: A 3-year non-comparative prospective clinical trial. SUBJECTS: The treatment with the FibroPlant-LNG intrauterine system (IUS), releasing 14 microg of LNG per day, was part of a regimen for estrogen substitution therapy in symptomatic postmenopausal women to prevent endometrial proliferation and bleeding. The majority of women received percutaneous 17 beta estradiol, 1.5 mg daily, or an equivalent dose by patch or orally, on a continuous basis. OUTCOME MEASURES: Menstrual pattern, endometrial histology and ultrasonographic evidence of endometrial suppression, after 3 years of use. RESULTS: The endometrial histology specimen showed profound endometrial suppression with glandular atrophy and stroma decidualization in all women. On transvaginal ultrasound, this corresponds with a thin endometrium (<5 mm) and clinically with a "bleed-free" menstrual pattern or amenorrhoea. CONCLUSION: The results of this 3-year study in 24 postmenopausal women using EST suggest that the FibroPlant-LNG IUS is effective in causing strong suppression of the endometrium during the entire period of EST. Target delivery in the uterine cavity could be the preferred route of administering a progestin to oppose estrogen stimulation of the endometrium.

Aged↗
PubMed2004

Assessment of menstrual blood loss in Brazilian users of the frameless copper-releasing IUD with copper surface area of 330 mm2 and the frameless levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of two types of IUDs on the amount of menstrual blood loss (MBL): the frameless copper-releasing intrauterine device (IUD) with copper surface area of 330 mm2 (GyneFix; Contrel Research, Ghent, Belgium) and the frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) releasing 14 microg per day (FibroPlant-LNG; Contrel Research). Heavy and abnormal MBL is the main reason for discontinuation of intrauterine devices. METHODS: In 20 Brazilian women using GyneFix 330 and 32 using FibroPlant-LNG, respectively, MBL was measured by the quantitative alkaline hematin technique. In addition, ferritin levels were measured in GyneFix 330 and FibroPlant-LNG users. RESULTS: MBL with GyneFix 330, measured over a 24-month period, increased but was less when compared with TCu380A. Ferritin levels with GyneFix 330 were not affected in contrast with TCu380A. In FibroPlant-LNG users, mean MBL decreased by about 90% and ferritin levels increased significantly. CONCLUSIONS: The authors confirm earlier reports that, especially for women with low body iron stores and heavy menstrual bleeding, there is an order of preference for IUD use to minimize MBL. The choice should first be a progestin-releasing IUS, then a copper IUD, which has the least effect on menstrual bleeding, such as the frameless GyneFix IUD.

Brazil↗
PubMed2004

Assessment of menstrual blood loss in women with ideopathic menorrhagia using the frameless levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of a "low-dose" levonorgestrel (LNG)-releasing intrauterine system (IUS) on the amount of menstrual blood loss (MBL) in women with ideopathic menorrhagia. METHODS: Menstrual blood loss was assessed with the visual assessment technique in 12 Belgian FibroPlant-LNG users with menorrhagia. In addition, ferritin levels were measured. RESULTS: The median MBL, evaluated by the visual scoring technique, decreased by more than 90%. The ferritin levels increased significantly during treatment with the levonorgestrel system. CONCLUSION: This study confirms previous MBL studies conducted with the FibroPlant-LNG IUS demonstrating the efficacy of the LNG-IUS to significantly reduce the amount of MBL in women with menorrhagia. The strong endometrial suppression is the principal mechanism explaining the effect on MBL. The therapeutic effect of this contraceptive method is highly desirable, particularly in women with heavy bleeding or anemia, as other treatment modalities are less effective, more costly, more invasive or inaccessible. The simple design characteristics and anchoring system account for minimizing the occurrence of complaints of pain and expulsion.

Female↗
PubMed2004

Assessment of menstrual blood loss in Belgian users of the frameless copper-releasing IUD with copper surface area of 200 mm2 and users of a copper-levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix 200 small) and a copper-levonorgestrel (GynePlant) intrauterine system (IUS) on the amount of menstrual blood loss (MBL). METHODS: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique. RESULTS: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant users, mean MBL scores decreased by at least 50% in all but one user. CONCLUSION: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL, without causing amenorrhea, can be obtained by adding levonorgestrel.

Adolescent↗
PubMed2003

Performance and acceptability of intrauterine release of levonorgestrel with a miniature delivery system for hormonal substitution therapy, contraception and treatment in peri and postmenopausal women.

OBJECTIVE: To evaluate the performance and acceptability of a novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), delivering approximately 14 microg per day. SUBJECT AND DESIGNS: A 1-year prospective clinical trial in 141 peri and postmenopausal women, including women with heavy or postmenopausal bleeding and women needing contraception. The majority received percutaneous 17beta-estradiol (Oestrogel), 1.5 mg daily. Clinical results and ultrasonographic effects were evaluated. RESULTS: Eighty-three insertions were done in perimenopausal women and 58 in postmenopausal women followed-up for 8-38 months. Fifty-two perimenopausal (64%) and virtually 100% of the postmenopausal women developed amenorrhoea, with occasional slight spotting. Eleven women with heavy bleeding, five of them with single or multiple intramural and subserosal fibroids of 3-6 cm or more, were all successfully treated, except one. There were no pregnancies. CONCLUSION: This study of 1432 women-months of use suggests that the frameless FibroPlant-LNG IUS is safe, well tolerated and effective in suppressing the endometrium during EST. The fact that the IUS also acts as a contraceptive, and significantly reduces menstrual bleeding, as demonstrated in earlier studies, is of added importance.

Adult↗
PubMed2003

Treatment of nonatypical and atypical endometrial hyperplasia with a levonorgestrel-releasing intrauterine system.

OBJECTIVE: A "frameless" intrauterine drug delivery system that releases 14 microg/d of levonorgestrel was used to treat nonatypical and atypical endometrial hyperplasia in 12 women. STUDY DESIGN: This noncomparative study had up to 3 to 4 years of follow-up. RESULTS: The cure rate was 100%, as confirmed by repeat endometrial biopsy. CONCLUSION: This method could be considered an alternative to hysterectomy.

Adenoma↗
PubMed2003

Miniature, low-dose, intrauterine drug-delivery systems.

The safety of systemically administered sex steroids continues to be a major focus of researchers. The negative results of the Women's Health Initiative study (WHI), and follow-up reports published in JAMA, evaluating the safety of estro-progestogen in postmenopausal women, elicited an unprecedented reaction in the press by women and doctors alike. From these publications, it is clear that research should focus on new progestogens and on alternative administration routes to minimize adverse drug effects. One approach to the improvement of safety, efficacy, and acceptability of steroid hormones, including patient compliance, is to develop long-acting implantable methods that deliver the lowest possible dose to the key target tissues. This therapeutic concept of "minimal intervention" has been known for several decades, but the practical applications of the method were lacking. Intrauterine drug-delivery systems can be developed to achieve minimal intervention fertility control without influencing normal ovarian function and/or causing adverse hormonal effects. With hormone replacement therapy in postmenopausal women, research suggests that progestogens delivered directly to the uterine mucosa could reduce side effects and minimize reversal of the beneficial effect of estrogens. Various "frameless" and "framed" intrauterine systems are currently being clinically evaluated. They are less troublesome than the available intrauterine systems and could therefore be suitable for use in the majority of women for contraception and treatment purposes (e.g., menorrhagia, hormone replacement). These systems require a single short office procedure, and have a low morbidity, which is undeniably linked with more invasive methods and systemic hormonal contraceptives. Due to the technological progress miniature, low-dose, long-term intrauterine drug-delivery systems offer enhanced effectiveness, reduced side effects, and optimal user compliance. Although there is minimal absorption in the systemic circulation, they deserve the status of a locally acting method that should be regarded as fundamentally advantageous, if effective, to systemically applied medications that may have potentially inherent ill side effects.

Adult↗
PubMed2002

Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study.

The objective of the study was to evaluate the contraceptive performance, acceptability, side effects, and adverse events of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) releasing 14 microg of LNG/day, in perimenopausal women. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss in women with or without fibroids. The study, consisting of 109 women, suggests that FibroPlant-LNG IUS is an effective contraceptive. No pregnancies occurred with the FibroPlant-LNG IUS. The total use-related discontinuation rate at 1 year is low (1.9) and results in a high rate of continuation of use (98.1). In addition, the FibroPlant-LNG IUS demonstrated a high level of effectiveness in reducing bleeding in women with excessive menstrual flow even when medium or large fibroids were present. However, an effect on the size of the fibroids could not be demonstrated. Patient satisfaction with the method is high, which is a prerequisite for continuance of the method, and may be linked with the advantageous design characteristics of the FibroPlant-LNG IUS, the virtual absence of hormonal side effects, and the low incidence of irregular bleeding and spotting even during the first 3 months after insertion of the FibroPlant IUS. Counseling remains important though to explain to women about the possible occurrence of changes in their menstrual pattern that may sometimes be annoying but harmless. It is concluded that many women over age 40 years could substantially benefit from the advantages of this intrauterine drug delivery technology which provides contraception and treatment of a possible associated condition such as menorrhagia. The treatment also creates the opportunity to pass through the transitional perimenopausal period smoothly and to benefit fully from the advantages hormone replacement therapy offers in terms of treatment of short-term symptoms and long-term prevention by gradually replacing the waning estrogens.

Adult↗
PubMed2002

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.

Abortion, Induced↗
PubMed2001

Treatment of menorrhagia with a novel 'frameless' intrauterine levonorgestrel-releasing drug delivery system: a pilot study.

OBJECTIVE: To evaluate the effect on menstrual blood loss of a novel 'frameless' intrauterine drug delivery system, the FibroPlant levonorgestrel intrauterine system (IUS), releasing 14 microg of levonorgestrel/day. An ancillary objective was to evaluate the contraceptive performance. STUDY DESIGN: This was an open-label, non-comparative ongoing pilot study. Thirty-two insertions were performed in fertile women aged between 31 and 51 years for the treatment of menorrhagia, as well as for contraceptive purposes. Fifteen women who developed excessive bleeding were fitted with the FibroPlant levonorgestrel IUS immediately following the removal of a copper-bearing intrauterine device (IUD), the GyneFix IUD. To discriminate between menorrhagia and normal menstrual blood loss, women were evaluated using a simple visual assessment technique. The trial covered a period from a minimum of 1 month up to 23 months. RESULTS: At the time of study analysis, the total number of woman-months was 361. Fourteen of the women had had the FibroPlant levonorgestrel IUS in place for more than 1 year, and 29 women for 6 months or more. All women reported greatly reduced bleeding. However, no cases of amenorrhea resulting from endometrial suppression were encountered. The reduction of bleeding was substantial after 1 month of treatment and decreased further over the next months to remain stable thereafter. The mean bleeding score before treatment was 338 (range 185-740) in the group who had had no prior use of an IUD and 368 (range 185-890) in the group with prior IUD use. The mean bleeding score dropped to a mean score of 70 (range 5-210) in the 'no prior IUD use' group and to a mean score of 52 (range 3-150) in the 'prior IUD use' group, after 1-23 months of follow-up. This result is highly statistically significant (p < 0.001). There were no statistical differences in bleeding scores before and during treatment between the two groups of women, with or without prior use of the copper IUD. Significant spotting was rare after the first 3 months following insertion. No complications (e.g. infection, expulsion or perforation) or pregnancies occurred. The FibroPlant levonorgestrel IUS was well tolerated by all women involved in the study and no systemic hormonal side-effects were reported. CONCLUSION: The FibroPlant levonorgestrel IUS is effective in significantly reducing the amount of menstrual blood loss in women with menorrhagia. Strong endometrial suppression is the principal mechanism explaining both the effect on menstrual blood loss and the contraceptive performance of the IUS. There were no differences in bleeding scores before and during treatment between the two groups of women with or without prior use of the copper IUD, suggesting that the development of heavy bleeding was not related to the use ofthe IUD. The therapeutic effect of this contraceptive method is highly desirable, particularly in women with heavy bleeding or anemia in developing countries, as other treatment modalities are less effective, more costly, more invasive or inaccessible. The low daily release rate of levonorgestrel from the FibroPlant levonorgestrel IUS results in a low incidence of hormonal side-effects and reduces the likelihood of amenorrhea. The simple design characteristics and revolutionary anchoring system minimize the occurrence of complaints of pain and the incidence of expulsion.

Adult↗
PubMed2001

Treatment of primary and secondary dysmenorrhea with a novel 'frameless' intrauterine levonorgestrel-releasing drug delivery system: a pilot study.

OBJECTIVES: To evaluate the effect on menstrual pain in women with primary and secondary dysmenorrhea of a novel 'frameless' intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) (Contrel Research, Belgium), releasing 14 microg of LNG per day. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss. STUDY DESIGN: An open label, non-comparative ongoing pilot study. Eighteen insertions were performed in women between 16 and 52 years of age by the first author. Four insertions were performed in nulligravid women. Eight women were categorized as having primary dysmenorrhea and 10 as having secondary dysmenorrhea. Twelve women complained of heavy bleeding. Three women had significant fibroids and three were suspected to have adenomyosis. RESULTS: The trial covers a period from a minimum of 3 months up to 33 months. By the end of August 2001, 12 recruited women had at least 12 months' follow-up and six had between 3 months and 1 year. All women reported much reduced pain, or no pain at all, and strongly reduced bleeding which started as soon as 1 month after insertion of the FibroPlant-LNG IUS. There was one exception; this woman had significant fibroids. She reported much reduced bleeding but this was not as pronounced as in the other women in the study. All women are continuing to use the method. CONCLUSION: The results of this preliminary study suggest that the FibroPlant-LNG IUS, releasing 14 microg ofLNG per day, is a safe and effective method for the treatment of primary and secondary dysmenorrhea. The absence ofa frame is particularly advantageous in these women. Of significant added importance is the high effectiveness in reducing menstrual bleeding, a symptom often present in women with menstrual pain complaints, and the fact that the system provides effective contraception. The low daily release rate of LNG from the FibroPlant-LNG IUS results in a virtual absence of hormonal side-effects.

Adolescent↗
PubMed2000

Endometrial suppression with a new 'frameless' levonorgestrel releasing intrauterine system in perimenopausal and postmenopausal women: a pilot study.

OBJECTIVE: A novel intrauterine drug delivery system, FibroPlant-levonorgestrel (LNG), derived from the frameless GyneFix intrauterine device (IUD) is described and the preliminary results in 30 symptomatic climacteric and postmenopausal women are discussed. The treatment with the FibroPlant-LNG intrauterine system (IUS) was instituted to suppress the endometrium during estrogen substitution therapy (EST) to prevent endometrial proliferation and bleeding. The purpose of the study was to evaluate the clinical and ultrasonographic effect of this new intrauterine progestin delivery system. METHODS: Two dosage forms were tested: the first 11 women received a 3-cm long coaxial fibrous delivery system, delivering approximately 10 microg per day of LNG; the remaining 19 women in the study received a 4-cm long delivery system, delivering approximately 14 microg per day. The calculated duration of release of the two systems is approximately 5 years. Twenty-two women were perimenopausal at the start of the treatment. Women in this study were observed for a duration of at least 1 year. Most postmenopausal women received percutaneous 17beta-estradiol (Oestrogel), 1.5 mg daily on a continuous basis. RESULTS: All postmenopausal women in the two groups reported amenorrhea during the entire study period (up to two and a half years follow-up). Endometrial atrophy in these women was confirmed by vaginal ultrasound examination. Seventeen of the 22 perimenopausal women reported amenorrhea at the first or second follow-up visit at 1 and 3 months following insertion of the IUS, respectively. The remaining had infrequent scanty bloody discharge needing a panty liner, at the most, for protection. There were no complications in this study (e.g. infection, expulsion or perforation). The FibroPlant-LNG IUS was very well tolerated by all the women and no systemic hormonal side effects were reported. There were no removals for medical reasons. CONCLUSION: The results of this pilot study suggest that the frameless FibroPlant-LNG IUS is safe, well tolerated and effective in suppressing the endometrium during EST. No differences could be clinically distinguished between the two dosages. Compliance was optimal. The fact that the IUS also acts as a potent contraceptive is of added importance.

Adult↗
PubMed2000

Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women.

This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.

Adolescent↗
PubMed2000

Immediate postabortal insertion of the frameless IUD: review of current experience.

Experience with the frameless Gynefix intrauterine device (IUD) for immediate postabortal insertion is growing. Reports confirm that the design characteristics of the frameless IUD (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high continuation rates. Insertion is easy and safe in the hands of trained providers and appears to be as reliable and effective as when inserted at interval. The results suggest that the frameless IUD may be an important new and affordable option to prevent repeat abortion.

Abortion, Induced↗
PubMed2000

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.

Adult↗