Functional ovarian cysts in premenopausal and gynecologically healthy women

The present study describes 29 women coincidentally found to have ovarian cysts while participating in a cross-sectional study. The prevalence of functional ovarian cysts is determined. In this study, 428 women, aged 14-45 years, were examined by transvaginal ultrasonography. The women were gynecologically healthy and were using either no contraception, intrauterine contraceptive devices, none of which were hormone releasing, or oral contraception (OC). Cysts were defined as cystic spaces larger than 30 mm. All women were asymptomatic and regularly menstruating.The prevalence of ovarian cysts was lower for women using OC than for women using no contraception or using intrauterine contraceptive devices. The relative risk (measured as the prevalence proportion ratio) of having an ovarian cyst when using OC was 0.22 (CI: 0.13-0.39), compared to women not using OC. No difference was found in the prevalence of ovarian cysts between women using intrauterine contraceptive devices and women using no contraception. The prevalence of ovarian cyst increased throughout the menstrual cycle in women not using OC. This relation was not found in the group of users of OC. The majority of the cysts resolved within the first few days of menstruation. Sixty-five percent of the cysts persisting after menstruation had resolved at the first control examination 3 months later, independently of use of OC. Low-dose monophasic contraceptive pills seem to have a protective effect against development of functional ovarian cysts, independent of the type of gestagen and the dose of ethinylestradiol used. Ovarian cysts resolved independently of treatment with OC. The use of intrauterine contraceptive device had no influence on the occurrence of functional ovarian cysts.     

Transition from Norplant to Jadelle in a clinic with extensive experience providing contraceptive implants

OBJECTIVE: The purpose of this study was to understand the transition process from providing Norplant, the six-capsule first contraceptive implant system, to providing Jadelle, the two-rod second-generation system, in a clinical setting with extensive experience providing Norplant implants. MATERIALS AND METHODS: Two hundred forty-nine women requesting contraceptive implants from the PROFAMILIA clinic (Santo Domingo, Dominican Republic) were provided with information regarding the differences and similarities between the two implant systems being studied, including the easier insertion and removal procedures and the possible shorter use life associated with Jadelle. A questionnaire evaluating their preference and the reason why they chose either system was provided. The health care providers' opinions about the two systems were also studied. RESULTS: Fifty-three percent of the women preferred Jadelle over Norplant. The main reason behind their preference for Jadelle was its reduced number of implants with easier insertion and removal and less visibility in the arm, whereas that for Norplant was greater familiarity. Providers overwhelmingly preferred Jadelle. A 1-h presentation was sufficient training for providers experienced with Norplant. None had any problem with the management of Jadelle. CONCLUSION: The inclusion of Jadelle in a clinic with extensive experience with Norplant was easy and uneventful, but both methods should be available during a transition period of several months while confidence in the new method is being acquired by the community.     

Location and removal of non-palpable Implanon implants with the aid of ultrasound guidance

BACKGROUND: Implanon insertion appears to be an easy procedure, but in a small minority of cases difficulties have been encountered with removal if the rod is impalpable. METHODS: Patients were referred to the contraceptive and sexual health service with non-palpable Implanon. Following a clinical assessment and examination of the arm where the implant had been inserted, an ultrasound examination was carried out to identify and locate the implant. These implants were subsequently removed, some under general anaesthesia and others under local anaesthesia. RESULTS: Twenty-seven patients were referred to the unit with impalpable Implanon rods. In four cases the rods were palpable and were removed in the clinic setting without the need for further intervention. Positive identification of the implants was achieved in 21 of the remaining 23 cases using ultrasound. No implant was detected in two cases and etonogestrel was not demonstrated serologically in either woman, suggesting non-insertion. All 21 Implanon rods identified by ultrasound were successfully removed. In just over 52% of women a previous attempt at removal had been undertaken prior to referral. CONCLUSIONS: It is possible to identify and locate impalpable Implanon rods with the aid of ultrasound, facilitating their subsequent safe removal. Although previous reports have identified the position of 'lost' implants using ultrasound, this is the first case series to discuss measuring the skin/implant depth. This parameter, together with the precise position of the implant (in muscle or fat), aids removal. All health professionals inserting and removing contraceptive implants should have been appropriately trained.     

Continuation rates of Implanon in the UK: data from an observational study in a clinical setting

BACKGROUND: Long-acting reversible methods of contraception can potentially reduce unintended pregnancy. There are few data on "real-life" continuation rates of the contraceptive implant Implanon. MATERIALS AND METHODS: Three hundred twenty-four women choosing Implanon in a community family planning clinic in Scotland were followed up by case note review (n=236) or postal questionnaire (n=87) 3 years after insertion of the implant (1 woman chose not to disclose her home address). RESULTS: Data were available for 85% of the women. Continuation rates were 89% (CI 84-91) at 6 months, 75% (CI 69-79) at 1 year, 59% (CI 52-63) at 2 years and 47% (CI 40-52) at 2 years and 9 months. Of the 68 women who discontinued Implanon within 1 year, 62 (91%) did so because of unwanted side effects, the most common being frequent and/or unpredictable bleeding (n=42, 62%). Almost half changed to a less-effective method of contraception; however, one third (n=99, 39%) chose to use a second implant when the first one expired. CONCLUSIONS: Continuation rates of Implanon in this clinic setting in the UK make it a cost-effective method of contraception and justify its widespread provision.     

Contraceptive implants and lactation

The safety and efficacy of four contraceptive implants, plant, Implanon, Nestorone and Elcometrine, have been evaluated during use in the postpartum period by lactating women. These implants provide highly effective contraceptive protection with no negative effect on breastfeeding or infant growth and development. Breastfeeding women initiating Norplant use in the second postpartum month experience significantly longer periods of amenorrhea than do untreated women or intrauterine device users. After weaning, the bleeding pattern is similar to that observed in non-nursing women. Norplant use does not affect bone turnover and density during lactation. Norplant and Implanon release orally active progestins while Nestorone and Elcometrine implants release an orally inactive progestin, which represents an advantage since the infant should be free of steroidal effects. The infant's daily intake of steroids (estimated from concentrations in maternal milk during the first month of use) range from 90 to 100 ng of levonorgestrel (Norplant), 75-120 ng of etonogestrel (Implanon), and 50 ng and 110 ng of Nestorone (Nestorone and Elcometrine implants, respectively). Nursing women needing contraception may use progestin-only implants when nonhormonal methods are not available or acceptable. Implants that deliver orally active steroids should only be used after 6 weeks postpartum to avoid transferring of steroids to the newborn.     

A randomized multicenter study comparing the efficacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant.

To compare the contraceptive efficacy, tolerability, and bleeding patterns, 200 healthy female volunteers received, in an open, comparative, randomized, multicenter study in China, either a single-rod (Implanon) or a six-capsule (Norplant) contraceptive implant for 2 years with an optional extension of up to 4 years. Women were exposed to Implanon for 341.6 woman-years and Norplant for 329.1 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding/spotting days with Implanon decreased from 33.5 in the first period to 19.0-21.5 days in the last year. Similarly, with Norplant, the median number of bleeding/spotting days decreased from 34.5 to 18.0-23.0 days, respectively. The number of bleeding/spotting episodes during year 1 was 2.0 per 90-day reference period with Implanon and 3.0 per period with Norplant (p < 0.05 for periods 1-4). For the remaining 90-day periods, there was no statistical difference between the two groups. In general, there was less frequent bleeding with Implanon compared with Norplant, whereas the incidences of amenorrhea and infrequent bleeding were higher with Implanon than with Norplant. The mean overall incidence of prolonged bleeding fell markedly during the study, from 66.0% in reference period 1 to 27.3% in period 16 with Implanon and from 69.0% to 21.7% with Norplant, respectively. The most common adverse events were related to disturbed bleeding patterns, which were also the major reasons for discontinuation (Implanon n = 8; Norplant n = 14). Normal menses returned in almost all subjects within 3 months after removal of the implants. Implanon was inserted in a mean time of 0.61 min and Norplant in 3.90 min (p < 0.001). Similarly, the mean time required to remove the implant was significantly shorter for Implanon than for Norplant (2.18 min vs 11.25 min, p < 0.001). The maximum time required for removal of the implant was 10 min for the Implanon group and 60 min for the Norplant group. In both groups, blood pressure and hemoglobin were not affected, whereas body weight tended to increase. It can be concluded that both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated. Compared with Norplant, there was less frequent bleeding with Implanon, whereas the incidence of infrequent bleeding and amenorrhea was higher. Implanon was significantly quicker to insert and to remove than was the multiple capsule system.     

Implanon use in Thai women above the age of 35 years

A prospective study of Implanon implant use in women older than 35 was conducted in Bangkok, Thailand. The purposes of this study were to evaluate the menstrual pattern and side effects of Implanon in 51 women followed for 6 months. Their mean age was 39.7 years. Most acceptors had completed primary school. No accidental pregnancies occurred in 6 months of use. The most common menstrual pattern in these acceptors was irregular bleeding followed by amenorrhea. The major side effect was irregular bleeding. There was no significant change in body weight, body mass index and diastolic blood pressure during the 6-month follow-up period, but systolic blood pressure declined. Implanon implant use is a safe and effective contraceptive method and should become another choice for contraception in women aged above 35 years who have contraindications for oral contraceptive use.     

Effect of Implanon use on selected parameters of thyroid and adrenal function

In this article, the effects of Implanon implant use on thyroid and adrenal function was compared with those of Norplant implants. In this 2-year open randomized study of 80 implant acceptors, we found that both implants may induce minimal changes in thyroid hormones and cortisol levels, possibly secondary to alterations in the respective binding globulins in the serum. These alterations in thyroid and adrenal function would have no clinical significance in healthy women. In the Norplant group, sex hormone-binding globulin levels decreased, whereas increased levels were found in the Implanon users at the end of 2 years. These findings lend support to the fact that etonogestrel, released from Implanon implants, is significantly less androgenic than levonorgestrel, released from the Norplant implants.     

Implanon users are less likely to be satisfied with their contraception after 6 months than IUD users

Background

The study was conducted to perform a direct comparison of the satisfaction of intrauterine device (IUD) users and Implanon users after 6 months.

Study design

Women were recruited to this study in the contraception clinics of Southern Health and Family Planning Victoria. Each woman completed a questionnaire at the time of starting her contraception with either an IUD or Implanon. Women were sent a follow-up questionnaire after 6 months to assess their satisfaction with their chosen method of contraception.

Results

A total of 439 participants were recruited for this non randomized cohort study; 211 choosing an IUD and 228 choosing to use Implanon. The main reason patients in both groups chose their contraceptive method was recommendation by the doctor. Follow-up was achieved in over 84% in both groups. More than 50% of women in both groups reported at least one side effect. The most commonly reported side effect in both groups was abnormal bleeding and this was also the most common reason for having the contraceptive device removed. The IUD users reported a higher rate of satisfaction with their chosen method of contraception, although there was no difference between groups in the removal rate or whether the women would recommend the contraception to others.

Conclusions

IUD users reported a higher level of satisfaction than did Implanon users at 6 months. Side effects in women using IUDs and Implanon are common. The range of likely side effects should be included in counseling women about long-term reversible contraception.     

Effect of Implanon and Norplant subdermal contraceptive implants on serum lipids--a randomized comparative study

The objective of this study was to assess the possible differences in effects of Implanon (etonogestrel 68 mg, single-rod) and Norplant (levonorgestrel 36 mg, six capsules) implants on serum lipids over 2 years of use. In this 2-year open randomized study of 80 implant acceptors, selected serum lipids were tested before implant insertion and at 6, 12 and 24 months after implant insertion. The lipid parameters evaluated were: total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides, apolipoprotein A-I and apolipoprotein B. During the 2 years, the serum lipid pattern in the Implanon users was not significantly different from that of the Norplant users. There was slight decrease in HDL-C levels in both the groups but there were no significant changes in the HDL/TC ratio and the HDL/LDL ratio. Although it was statistically significant, the magnitude of decrease in HDL-C from preinsertion levels in Implanon users was only 5.8% at the end of 2 years.     

Implantable contraceptives for women: effectiveness, discontinuation rates, return of fertility, and outcome of pregnancies

Progestogen-only contraceptive implants are highly effective. In most studies, 5-year cumulative pregnancy rates are less than 1.5/100 women for Norplant and Norplant II. No study has yet reported any failures with Implanon. Weight over 70 kg and age at insertion under 25 years both increase the failure rate of Norplant and Norplant II; however, data are as yet lacking for Implanon. The effectiveness of other progestogen-only implants for which there are as yet few data are unlikely to be any different. Continuation rates are high compared with other hormonal methods and with the intrauterine device. In most cohorts at least 35% of women, and often many more, are still using Norplant by the end of 5 years. Rates vary according to a number of factors, including population studied, age, and parity. Menstrual disturbance is by far the most common reason for discontinuation, with headache, acne, weight gain, and desire for pregnancy accounting for other common reasons for implant removal. Fertility returns rapidly following implant removal, and pregnancy rates (76-100% 1 year after removal) are usually no different from those following discontinuation of any other contraceptive method. There is no increase in the risk of ectopic pregnancy, fetal malformation, or impaired infant health in pregnancies conceived either during implant use or after removal.     

Effect of etonogestrel subdermal contraceptive implant (Implanon) on liver function tests -- a randomized comparative study with Norplant implants

OBJECTIVE: The study aimed to assess the possible differences in effects of Implanon and Norplant implants on liver function over 2 years of use. METHODS: This is a 2-year open randomized study of 80 implant (Implanon and Norplant) acceptors. Selected parameters of liver function were tested in the serum before implant insertion and at 6, 12 and 24 months after implant insertion. RESULTS: In both the implant groups, the mean total and unconjugated bilirubin and the gamma-glutaryl transferase levels were significantly raised during implant use. For none of the subjects, at any sampling period, did the levels exceed the normal range in our population. There was no significant elevation of any other liver enzymes in either group. CONCLUSION: It appears that there may be mild hepatocellular dysfunction associated with the use of both Implanon and Norplant, which is possibly of no clinical significance to the healthy acceptor.     

Implanon contraceptive implants: effects on carbohydrate metabolism

The objective of the study was to assess the possible differences in effects of Implanon and Norplant implants on carbohydrate metabolism. This is a 2-year open randomized study of 80 implant (Implanon and Norplant) acceptors. Oral glucose tolerance test (OGTT) was performed before implant insertion and at 6, 12, and 24 months after implant insertion. Glycosylated hemoglobin A(1)C was measured in fasting samples and plasma samples during OGTT were tested for glucose and insulin levels. There was a significant increase in the area under the curve for both glucose and insulin during OGTT within each group with increasing duration of use. However, there was no significant change in the fasting plasma glucose values. There was no significant difference in the carbohydrate parameters between the two groups during implant use, except for a minimal but statistically significant rise in fasting glycosylated hemoglobin A(1)C levels at 24 months in the Implanon group. Both implants appear to induce mild insulin resistance but no significant change in serum glucose levels. These alterations in carbohydrate metabolism should have no clinical significance in healthy women.     

Matched-pairs analysis of ovarian suppression during oral vs. vaginal hormonal contraceptive use

Background

This study was conducted to compare ovarian suppression during oral vs. vaginal hormonal contraceptive use. Secondary aims included comparison of endometrial thickness and bleeding patterns.

Methods

In two open-label trials assessing ovarian suppression, 33 compliant women completed both studies. They first used oral contraceptive pills (OCs) [randomized to either 20 mcg ethinyl estradiol (EE)/100 mcg levonorgestrel (LNG) or 30 mcg EE/150 mcg LNG] and subsequently used contraceptive vaginal rings (CVRs) (daily release of 15 mcg EE/120 mcg etonogestrel), all 21/7-day regimens. Participants had at least one run-in cycle using each contraceptive method prior to evaluation. During one cycle of each method, women underwent biweekly transvaginal sonography to measure ovarian follicular diameters and endometrial thickness. We also noted presence of a corpus luteum or a ruptured follicle as a marker of ovulation. Participants recorded bleeding days on paper calendars. We used matched-pairs analyses as appropriate.

Results

During follow-up, we identified at least one ovarian follicle ≥8 mm in 20/33 (61%) OC users and 12/33 (36%) CVR users (matched-pairs analysis, p=.02). Similar trends were seen for larger follicles; however, we had limited statistical power to evaluate these differences. Median follicular diameter among OC users was larger than median follicular diameter among CVR users (p=.01). We did not observe a corpus luteum or ruptured follicle in any participant during either study. Endometrial thickness was similar during OC and CVR use (mean 4.1±1.4 vs. 4.1±1.6 mm, p=.9), as was the number of bleeding or spotting days (mean 2.1±2.4 vs. 1.9±2.1, p=.8). Oral contraceptive pill dose was unrelated to follicle diameter, endometrial thickness or bleeding.

Conclusions

Ovarian follicles ≥8 mm were more common in 33 compliant women during OC use than during CVR use, indicating that CVR use results in greater ovarian suppression than OC use.     

Removal of etonogestrel contraceptive implants in the operating theater: report on 28 cases

OBJECTIVES: We describe removal procedures for etonogestrel contraceptive implants in the operating theater. In addition, we discuss the management of removal of contraceptive implants that are difficult to palpate or are impalpable. DESIGN: We conducted a retrospective single-center case series analysis of Implanon removals conducted at a university hospital between January 2002 and April 2005. MATERIALS AND METHODS: We analyzed case notes for 28 patients who had their contraceptive implant removed in the operating theater. RESULTS: Intermenstrual bleeding was the principal reason for removal (52.4%). Ten patients already had one attempted removal of their implant. Preoperative ultrasound localized the implant in all cases. Half of the removals were done under local anesthetic, with three cases progressing to general anesthesia (11%). Thirty percent of the implants had migrated from their initial implantation, 37% were in intramuscular tissue and 11% were in the humeral neurovascular sheath. The only postoperative complications were one small seroma and transient paresthesia in the territory of the ulnar nerve. The implant was not found in one case. CONCLUSIONS: The removal of an implant that is not palpable or difficult to palpate should take place in the operating theater following localization by ultrasound. Patients must be fully informed about the procedure, including its complications and the risk for failure.     

Comparison of ovarian follicular activity during treatment with a monthly injectable contraceptive and a low-dose oral contraceptive

Ovarian follicular development occurs during treatment with combined and progestin-only oral contraceptive (OC) pills and progestin-containing subdermal implants, and can be associated with the development of persistent functional cysts that may require surgical removal. Lunelle is a once-a-month injectable contraceptive containing estradiol cypionate 5 mg and medroxyprogesterone acetate 25 mg. A randomized, comparative study was undertaken to compare the effect on ovarian follicular activity associated with use of Lunelle and a low-dose OC. A total of 30 ovulatory subjects were randomly assigned to receive two cycles of treatment with either an OC containing ethinyl estradiol 20 microg and 0.1 mg levonorgestrel or Lunelle. During the second cycle of treatment, pelvic sonography was performed every 4 days, at which time the maximum follicle diameter was measured. Study end points were the presence of follicles >/=10, 20, and 30 mm. In all, 13 of 15 subjects in the OC group and 14 of 15 in the Lunelle group completed the study. Follicles measuring >/=10 mm were present in 11 of 13 (84.6%) in the OC users and in four of 14 (28.6%) in the Lunelle users (p <0.05). In the OC group, six of 13 subjects (46.1%) developed follicles >/=20 mm, and one of 13 (7.7%) developed follicles >/=30 mm. No subjects in the Lunelle group developed a follicle >/=20 mm in diameter. This study indicates that Lunelle is associated with a significantly lower incidence of ovarian follicular development compared to that of an OC containing 20 microg ethinyl estradiol and 0.1 mg levonorgestrel.     

Metabolic effects of implantable steroid contraceptives for women

The metabolic impact of progestin-only contraceptives is less than that of combined oral contraceptives. Subdermal contraceptive implant systems that provide a sustained release of low levels of progestins are now becoming widely available. This review evaluates the metabolic effects of currently available products that release the progestins levonorgestrel (Norplant, Jadelle, and their Chinese equivalents); etonogestrel (Implanon); nomegestrol acetate (Uniplant); and Nestorone, formally called ST-1435 (Nestorone implant/Elcometrine). Data on liver, kidney, and renal function; carbohydrates and insulin release; hemostasis; blood pressure; and lipids are considered. The metabolic effects reported for these methods as a whole were minimal. Any changes were generally within the normal range for the populations studied and, therefore, are unlikely to be of clinical significance. However, all published studies have been conducted in healthy populations of women. To inform clinical practice, the field would be well served to have additional empiric data from well-designed, well-implemented, and well-reported trials in women who are deemed to be at elevated risk for certain diseases including cardiovascular disease and diabetes.     

Implanon as a contraceptive choice for teenage mothers: a comparison of contraceptive choices, acceptability and repeat pregnancy

Background

This study was conducted to compare the incidence of repeat teenage pregnancy over a 24-month period postpartum among users of Implanon, the combined oral contraceptive pill (COCP) or depot medroxyprogesterone acetate (DMPA) and barrier methods or nothing (barrier/none). Contraceptive continuation rates 24 months postpartum for Implanon and COCP/DMPA were also compared.

Study Design

A prospective cohort study was conducted. Comparison groups were postpartum teenagers (12-18 years old) who self-selected Implanon (n=73), COCP/DMPA (n=40) and barrier/none (n=24). Questionnaires were used to gather data at recruitment and postpartum at 6 weeks and then 3 monthly intervals for 2 years.

Results

At 24 months postpartum, 48 (35%) teenagers had conceived. Implanon users became pregnant later than other contraceptive groups (p=.022), with mean time to first repeat pregnancy of 23.8 months [95% confidence interval (CI), 22.2-25.5], compared to 18.1 months (95% CI, 15.1-20.7) for COCP/DMPA and 17.6 months (95% CI, 14.0-21.3) for barrier/none. Implanon users were more likely to continue their use at 24 months than COCP/DMPA (p<.001) users. The mean duration for Implanon users was 18.7 months (95% CI, 17.0-20.3) compared to 11.9 months (95% CI, 9.5-14.3) for COCP/DMPA.

Conclusion

Teenagers who choose Implanon are significantly less likely to become pregnant and were found to continue with this method of contraception 24 months postpartum compared to those who choose COCP or DMPA and barrier methods or nothing.     

Nonpalpable ultrasonographically not detectable Implanon rods can be localized by magnetic resonance imaging

Recently, the contraceptive implant Implanon has been introduced in several European countries. In comparison to the six-capsule preparation Norplant, the removal of this single-rod system should be associated with less complications. However, the removal of nonpalpable Implanon rods can be difficult because the implant is not always visible with ultrasound. The aim of this study was to find a radiologic method for the localization of Implanon implants that are nonpalpable and can not be detected by ultrasound. X-ray, ultrasound, computed tomography, and magnetic resonance imaging (MRI) were investigated as methods to localize Implanon in a pig chest preparation and in a woman with a nonpalpable implant. The implant in the woman could be localized unequivocally only by MRI. We conclude that MRI is the best method for the unequivocal localization of nonpalpable, ultrasonographically not detectable Implanon rods. To avoid unnecessary scar tissue formation, it may be appropriate to defer surgery for the removal until definitive localization.     

An assessment of the first 3 years' use of Implanon in Luton

OBJECTIVES: Implanon was introduced in the UK in September 1999. We present here the results of our first 106 Implanon insertions, performed over a period of 18 months. The aims of the study were to study the clinical and demographic profile of Implanon users, to assess the continuation rates of Implanon in the local population, and to identify the reasons for removal. METHODS: This was a case note-based study in which the data were transferred to a standardised pre-tested proforma. RESULTS: The age range of the 106 Implanon users was 15-43 years. Eighty-six of these clients had their Implanon removed and the Implanon status of 20 clients is not known since they were lost to follow-up by our service. Of these 86 cases, 26 had completed the full 3-year period; therefore, the continuation rate at 3 years was 30.2%. The continuation rate at the end of 1 year was 69.8% and at 2 years was 44.1%. Of the 60 women who had their Implanon removed before the recommended 3-year period, the most common reason was for bleeding irregularity (24 cases, 40%). CONCLUSIONS: This is the first published study set in the UK within a real-life setting to follow up a cohort of Implanon users for the full 3-year period. No contraceptive failures were found, replicating previous clinical trials. The continuation rate in this real-life situation was quite low compared to clinical trials. This is frequently the case when comparing real-life situations with clinical trials and may be in part due to higher motivation on the part of clinical trial participants.