OBJECTIVE: The aim of this study was to determine whether women experience significant luteal phase hormonal changes following interval tubal sterilization. DESIGN: This is a partly randomized, prospective clinical study. SETTING: This study involved healthy volunteers in an academic research environment. PATIENTS: This study involved 118 fertile women seeking tubal sterilization and 57 fertile controls with at least three normal cyclic menstrual periods before entry into the study. INTERVENTIONS: The patients were randomized to bipolar cautery or Hulka clip as sterilization methods. Barrier contraception or abstinence was used by controls. MAIN OUTCOME MEASURES: The main outcome measures are serum estradiol and progesterone levels and urinary estradiol and pregnanediol levels obtained during the luteal phase before, 1 year and 2 years after sterilization. RESULTS: The women randomized to the bipolar cautery group had higher midluteal progesterone levels measured between Days 5 and 11 postovulation (15.5 ng/mL before sterilization, 14.5 ng/mL at 1 year and 14.5 ng/mL at 2 years) than did the other two groups. The clip group had progesterone levels of 14.1, 12.0 and 12.5 ng/mL at baseline, 1 year and 2 years, respectively, and the control group had levels of 12.0, 11.9 and 11.3 ng/mL for the same periods. Serum estradiol and progesterone and urinary pregnanediol and estradiol were not significantly changed over the 2-year period, nor were there significant differences between the two groups. CONCLUSIONS: There were no significant hormonal changes in sterilized women over a period of 2 years when compared with their baseline levels or when compared with unsterilized age-matched controls.
RCT Entities:
OBJECTIVE: The aim of this study was to determine whether women experience significant luteal phase hormonal changes following interval tubal sterilization. DESIGN: This is a partly randomized, prospective clinical study. SETTING: This study involved healthy volunteers in an academic research environment. PATIENTS: This study involved 118 fertile women seeking tubal sterilization and 57 fertile controls with at least three normal cyclic menstrual periods before entry into the study. INTERVENTIONS: The patients were randomized to bipolar cautery or Hulka clip as sterilization methods. Barrier contraception or abstinence was used by controls. MAIN OUTCOME MEASURES: The main outcome measures are serum estradiol and progesterone levels and urinary estradiol and pregnanediol levels obtained during the luteal phase before, 1 year and 2 years after sterilization. RESULTS: The women randomized to the bipolar cautery group had higher midluteal progesterone levels measured between Days 5 and 11 postovulation (15.5 ng/mL before sterilization, 14.5 ng/mL at 1 year and 14.5 ng/mL at 2 years) than did the other two groups. The clip group had progesterone levels of 14.1, 12.0 and 12.5 ng/mL at baseline, 1 year and 2 years, respectively, and the control group had levels of 12.0, 11.9 and 11.3 ng/mL for the same periods. Serum estradiol and progesterone and urinary pregnanediol and estradiol were not significantly changed over the 2-year period, nor were there significant differences between the two groups. CONCLUSIONS: There were no significant hormonal changes in sterilized women over a period of 2 years when compared with their baseline levels or when compared with unsterilized age-matched controls.