Objective To report the first clinical evaluation of a new balloon endometrial, thermal destruction system CavatermTM, for outpatient treatment of menorrhagia. Design To elucidate possible technical problems during treatment, to evaluate how the patients tolerated the treatment and to judge which patients were suitable for this form of treatment. Main outcome measures Measurements of bleeding volumes in pads and tampons before and after treatment were performed as well as subjective evaluation by bleeding charts. Patients also estimated their degree of satisfaction. Setting Gynaecology department at a university hospital. Subjects 36 patients under 52 years of age with menorrhagia, without suspicion of intracavitary pathology including malignancy. Results No procedure‐related complications occurred. The patients tolerated the treatment well. There was a significant reduction in measured bleeding volumes in pads and tampons, collected during one menstruation, 2–7 months after treatment compared with measurements before treatment. Four patients subsequently underwent hysterectomy and should not have been included in the study (two with pedunculated myoma and one with a septum; the fourth showed premalignant endometrial changes in the curettage preceding the treatment). At 18–28‐month follow up, 29 of the suitable patients (91%) reported a significant reduction in bleeding and another three patients reported reduced but still profuse bleeding compared with pretreatment; 88% (28/32) rated the treatment results as excellent, and a further 9% (3/32) as good. Conclusions We found the CavatermTM system for endometrial destruction to be safe, efficient and easy to use.

In a population-based case-control study, possible risk factors for ectopic pregnancy were compared in 119 patients with ectopic pregnancy and in 119 age-matched controls with intra-uterine pregnancy from each of the following categories: deliveries, spontaneous abortions and induced abortions. The following factors were found significantly more often in cases of ectopic pregnancy: a history of earlier ectopic pregnancy, a history of salpingitis, a history of earlier operation on the Fallopian tubes, a history of infertility, and a pregnancy that had occurred in spite of an intra-uterine contraceptive device. A history of appendectomy was also found significantly more often among the cases. There was no significant correlation between ectopic pregnancy and a history of no earlier pregnancy, earlier deliveries, earlier spontaneous or induced abortions or a history of other gynecological operations and increased risk of ectopic pregnancy. One or more of the risk factors were found in 76.5% of cases and 23% of controls.

Findings in in vitro and in vivo experiments suggest that 30 min heating of the endometrium to 58-65 degrees C with an intrauterine silicone balloon filled with a liquid to a pressure of 180 mmHg exerts therapeutic effects on both endometrium and uterine cavity smooth muscle cells without damage to surrounding tissues.

Objective To study the long‐term results of treatment for menorrhagia involving the thermal destruction of the endometrium by means of a balloon catheter. Design Between August 1993 and December 1996, 117 women were treated and, in a prospective study, 116 (99%) of them were followed up with consultations and questionnaires. No pretreatment with gonadotrophin‐releasing hormone (GnRH) analogues was given. Setting Gynaecology department at a university hospital. Results There were no immediate peroperative complications. The success rate after 25 months (range 10–49) was 94%, excluding women with preoperative intracavitary changes and pretreatment ultrasonographically identified submucosal leiomyomas. Life‐table analysis showed that the probability of assessing the treatment as ‘excellent’ or ‘good’ and avoiding hysterectomy over a 49‐month period was 81%, and the probability of avoiding hysterectomy over the same time period was 85% when no exclusions were made. Conclusions For women with menorrhagia, who have no further wish for pregnancy, this study shows that thermal endometrial destruction by means of the balloon catheter technique is a safe type of day case procedure with a high success rate. Pretreatment examination is important in order to select women well suited for the treatment. A successful result 1 year after treatment implies a successful result in the long term.

Of 159 pregnancies conceived after clomiphene therapy, 141 ended in childbirth, including seven sets of twins. There was a probable increase in the number of infants born with major malformations. These were exclusively to women who had not previously borne a normal infant. The incidence of malformed infants compares well with that published after gonadotropin therapy. The possibly higher incidence of malformations seen after drug-induced ovulation would therefore seem to be due to the underlying subfertility state and thus not a direct drug effect.