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  • Title: Timing of onset of contraceptive effectiveness in Norplant implant users. Part I. Changes in cervical mucus.
    Author: Dunson TR, Blumenthal PD, Alvarez F, Brache V, Cochon L, Dalberth B, Glover L, Remsburg R, Vu K, Katz D.
    Journal: Fertil Steril; 1998 Feb; 69(2):258-66. PubMed ID: 9496339.
    Abstract:
    OBJECTIVE: To provide scientific data regarding the changes in cervical mucus within the first hours to days after Norplant implant insertion and to estimate when the cervical mucus is hostile enough to suggest a contraceptive effect. DESIGN: Multicenter, clinical descriptive study. SETTING: Family planning clinics. PATIENT(S): Forty-two women who were between days 8 and 13 of their menstrual cycle and who had requested Norplant implants were admitted to the study. INTERVENTION(S): Cervical mucus and blood samples were obtained. MAIN OUTCOME MEASURE(S): Cervical mucus scores, sperm penetration distances, and serum levels of progesterone, estradiol, and levonorgestrel. RESULT(S): The median cervical mucus score observed at baseline was 6 ("fair"), indicating that the mucus was already somewhat hostile before insertion of the Norplant implants. The median scores declined to 5 at 12 and 24 hours and continued to decrease through day 7 to 2 ("poor"), a score that is judged as hostile to sperm penetration. Overall, 73% of all subjects had a poor cervical mucus score by 3 days after insertion; at 7 days after insertion, 90% exhibited poor mucus and none had a good score. There was a substantial drop in the overall median distance traveled by the vanguard sperm after 12 hours for each cervical mucus score grouping. The distance traveled decreased rapidly between 12 and 24 hours to < 0.5 cm in subjects with fair and poor mucus, and by day 3, 91% of the subjects exhibited poor sperm penetration. CONCLUSION(S): On the basis of our findings, deterioration of the quality of the cervical mucus and sperm penetration is evident by 24 hours after insertion, although not to a level that would suggest adequate protection until 72 hours after insertion. Therefore, we are confident in recommending that backup methods of contraception (e.g, condoms) need not be used for more than 3 days after insertion, even when the implants are inserted close to ovulation. These findings provide policy makers, clinic managers, and clinicians with important information about how they can improve client access to Norplant implants. To provide clinicians with evidence as to when the cervical mucus is hostile enough in new Norplant implant acceptors to indicate a contraceptive effect, 42 women requesting Norplant from clinical sites in Santo Domingo, Dominican Republic, and Baltimore, Maryland (US), in 1994-95 were enrolled in a clinical descriptive study. At baseline, when all women were between days 8 and 13 of their menstrual cycle, the median cervical mucus score was 6 ("fair") out of a possible maximum of 12. This score declined to 5 at 12 and 24 hours and continued to decrease through day 7, when it reached 2--a level judged hostile to sperm penetration. Overall, 73% of women had a "poor" cervical mucus score by day 3 and 90% were in this category by day 7. There were substantial drops in the overall median distance travelled by the vanguard sperm and in the percentage of subjects demonstrating poor sperm penetration after 12 hours for each cervical mucus score grouping. 91% of women had poor sperm penetration by day 3 and 93% by day 7. These findings suggest that backup contraceptive protection for the entire cycle after Norplant insertion--a standard recommendation--is not necessary given the profound effect of levonorgestrel on cervical mucus shortly after insertion, even in the event of possible ovulation.
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