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Objective To evaluate the efficacy,bleeding profile and safety of low-dose levonorgestrel-releasing intrauterine system (LNG-IUS 8) in Chinese healthy women of childbearing age.Methods A multi-center,open-label,single-arm clinical trial conducted at 16 centres in China enrolled 773 healthy women of childbearing age (mean age 31.6 years old,range 18 to 40 years old),who demanded contraception,from April 2006 to June 2013.All women placed LNG-IUS 8 for 3 years and then been followed up at 3,6,9,12,18,24,30,36 months.The efficacy variables including pregnancy rate and expulsion rate were analyzed using life table,while observing adverse events (AE) to evaluate the safety.The bleeding profile happened during the study was assessed using 90-day reference intervals (World Health Organization criteria).Results Eight pregnancies occurred among 773 women,resulting in a overall Pearl index of 0.42 per 100 women years.The 3-year cumulative pregnancy rate was 0.37 per 100 women years and the 3-year cumulative expulsion rate was 1.99 per 100 women years.The number of women with bleeding/spotting reduced and the bleeding/spotting days declined over time.Totally 219 AE were reported related to LNG-IUS 8 placements.The most common AE were vaginal bleeding (8.2％,63/773)and the ovarian cyst (6.2％,52/773).LNG-IUS 8 had an improving effect on dysmenorrhea that the percentage of women with dysmenorrhea as well as the days of dysmenorrhea decreased over time.The percentage of women satisfied or very satisfied with LNG-IUS 8 was 87.2％ (622/713).Conclusion LNG-IUS 8 is highly effective and safe for Chinese healthy women of childbearing age.
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<p><b>OBJECTIVE</b>To determine an optimal insemination technique for unexplained infertility patients undergoing IVF or ICSI following failed intrauterine insemination (IUI).</p><p><b>METHODS</b>Sixty-five cycles of 61 patients with failed IUI were divided into four groups: Group A (37 cycles of IVF), Group B (19 cycles of ICSI), Group C (4 cycles of IVF and ICSI: half and half), Group D (5 cycles of ICSI after failed IVF). The conventional IVF cycles were defined as Group E (37 cycles), and the conventional ICSI cycles defined as Group F (24 cycles). The fertilization rate, completely failed fertilization rate, high quality embryo rate, clinical pregnancy rate and the implantation rate were compared among all the groups.</p><p><b>RESULTS</b>There were statistically significant differences in the fertilization rate, completely failed fertilization rate between Groups A and E (55.4% vs 72.8%, P < 0.05; 21.6% vs 0%, P < 0.005), and Groups A and B (55.4% vs 68.4%, P < 0.05; 21.6% vs 0%, P < 0.01). In Group D, there was statistically significant difference in the fertilization rate between IVF cycles and ICSI cycles (12.2% vs 74.2%, P < 0.005).</p><p><b>CONCLUSION</b>The present study demonstrates that there may be 20% of totally failed fertilization in IVF cycles with unexplained primary infertility following failed IUI, and ICSI treatment can increase fertilization rate and avoid complete fertilization failure.</p>