Objective(s): To study the prevalence of persisting ovarian follicles and to assess the endometrial changes and patterns of vaginal bleeding over 1 year of use of a 20 micrograms/24 h levonorgestrel-releasing intracervical contraceptive device.
Design: Prospective, randomized study.
Setting: Two family planning clinics in Helsinki, Finland.
Patient(s): Women requesting intrauterine hormonal contraception.
Intervention(s): Insertion of a levonorgestrel-releasing intracervical contraceptive device into the cervical canal (group 1, n = 151) or fundally into the uterine cavity (group 2, n = 147) for contraception.
Main outcome measure(s): Transvaginal ultrasonography of the ovaries and endometrium at insertion and 3, 6, and 12 months after insertion. Data on bleeding were collected using menstrual diary cards.
Results: Persisting ovarian follicles were found in < 8% of women. In both groups, the amount of endometrial tissue decreased significantly in 3 months. The incidence of amenorrhea during the 1st year was higher in the fundal insertion group.
Conclusion(s): The number of persisting follicles was low. Follicles resolved within 6 to 8 weeks. No association was found between persisting follicles and problems of bleeding. Compared with intracervical insertion, fundal insertion resulted in more uniform endometrial suppression and fewer days of bleeding and spotting.
PIP: The prevalence of persisting ovarian follicles as well as endometrial changes and vaginal bleeding patterns associated with the levonorgestrel-releasing intracervical contraceptive device were investigated in a 12-month prospective study involving 398 women recruited from 2 family planning clinics in Helsinki, Finland. The device, which released 20 mcg of levonorgestrel per 24 hours, was inserted into the cervical canal in 151 women and fundally into the uterine cavity in the remaining 147 women. Transvaginal ultrasonography of the endometrium and ovaries was performed at insertion and at 3, 6, and 12 months post-insertion. The prevalence of persisting ovarian follicles was 6.5% at 3 months, 7.7% at 6 months, and 3.2% at 12 months, with no significant differences between the 2 study groups. All but 1 follicular structure resolved spontaneously within 6-8 weeks of follow-up. In both groups, endometrial tissue thickness decreased significantly by 3 months and remained thin for the duration of the study. The number of days of bleeding, documented through menstrual diaries, decreased slowly in the cervical group, from 4.0 in the first month to 2.0 in the sixth month and 1.0 in the 12th month; however, a very steep decrease occurred in the fundal insertion group, from 5.0 in the first month to 1.0 in the sixth month and 0.0 in the 12th month. 11% of women in the intracervical insertion group compared with 24% in the fundal insertion group experienced at least 1 continuous 90-day amenorrhea episode. There was no correlation between functional ovarian cysts and bleeding patterns. Although fundal insertion of an intracervical contraceptive device results in more uniform suppression of the endometrium, women who consider amenorrhea undesirable should have the device inserted cervically.