Very Early Pregnancy Data Favor Myomectomy

NICE, FRANCE — Preliminary results from a prospective randomized trial in the Czech Republic show more women of reproductive age becoming pregnant after myomectomy than after uterine fibroid embolization.

Ten pregnancies were reported among 18 women who tried to conceive after uterine fibroid embolization (UFE). Twenty pregnancies occurred among 30 patients who sought to become pregnant after myomectomy.

So far, two babies have been born to mothers who had embolization, and 10 babies have been born to mothers who underwent myomectomy.

The investigators have declined to draw conclusions on outcomes at this point, however, because the number of women attempting pregnancy after embolization was relatively small.

“In terms of fertility, these are preliminary results. We draw no conclusion at the moment in terms of outcomes,” investigator Michal Mara, M.D., Ph.D., told this newspaper after she presented data at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“I think in the group with UFE, there were fewer patients trying to conceive at the moment. It was too small,” he said, adopting a watch-and-wait approach for the ongoing study.

The trial randomized 49 women to embolization and 56 to myomectomy (33 laparoscopic procedures and 23 open myomectomies were performed).

Both groups had an average age of 32 years, a mean of two fibroids per patient, as well as “a negative reproductive history,” according to Dr. Mara, who is in the department of obstetrics and gynecology at Charles University in Prague.

Fewer than half the women in either group had ever been pregnant, and roughly three-fourths had not delivered a baby. Infertility was reported in 11 embolization patients and in 26 women in the myomectomy group.

Hospital stays were significantly shorter with embolization (3.6 days vs. 4.7 days with myomectomy). Full recovery was also faster with embolization (12.1 days vs. 24.2 days). However, short-term complications were comparable at 18% for each cohort.

Post-30-day results were available for 44 embolization patients and 49 myomectomy patients who had been followed for an average of 19 months.

Dr. Mara noted that both groups showed technical success and symptom relief in more than 90% of study patients.

Although late complications were slightly higher with embolization, the difference was not significant.

Trial participants were allowed to attempt conception 6 months after their respective procedures.

“Unfortunately, the numbers of pregnant patients are quite low,” Dr. Mara said.

He and his collaborators reported five abortions and one termination in the embolization cohort.

There were four abortions in the myomectomy group, which also had one ectopic pregnancy.

Nine births were by cesarean section, which was elective in most cases, according to Dr. Mara.

At the time of his presentation, two of the women from the embolization group and five of the women from the myomectomy group were pregnant.

Dr. Mara began his discussion with an anecdote tracing his decision to initiate the trial to his experience with a patient who had aborted twins because of fibroids.

He recalled seeking advice from his colleagues on how to treat the woman, as she had still hoped to bear a child.

“I asked five of them, and I received five different recommendations,” on how to treat the patient, Dr. Mara said.

“From the point of view of the gynecologist, if you want to treat fibroids, this is crucial—the desire of women to get pregnant,” he added.

NICE, FRANCE — Preliminary results from a prospective randomized trial in the Czech Republic show more women of reproductive age becoming pregnant after myomectomy than after uterine fibroid embolization.

Ten pregnancies were reported among 18 women who tried to conceive after uterine fibroid embolization (UFE). Twenty pregnancies occurred among 30 patients who sought to become pregnant after myomectomy.

So far, two babies have been born to mothers who had embolization, and 10 babies have been born to mothers who underwent myomectomy.

The investigators have declined to draw conclusions on outcomes at this point, however, because the number of women attempting pregnancy after embolization was relatively small.

“In terms of fertility, these are preliminary results. We draw no conclusion at the moment in terms of outcomes,” investigator Michal Mara, M.D., Ph.D., told this newspaper after she presented data at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“I think in the group with UFE, there were fewer patients trying to conceive at the moment. It was too small,” he said, adopting a watch-and-wait approach for the ongoing study.

The trial randomized 49 women to embolization and 56 to myomectomy (33 laparoscopic procedures and 23 open myomectomies were performed).

Both groups had an average age of 32 years, a mean of two fibroids per patient, as well as “a negative reproductive history,” according to Dr. Mara, who is in the department of obstetrics and gynecology at Charles University in Prague.

Fewer than half the women in either group had ever been pregnant, and roughly three-fourths had not delivered a baby. Infertility was reported in 11 embolization patients and in 26 women in the myomectomy group.

Hospital stays were significantly shorter with embolization (3.6 days vs. 4.7 days with myomectomy). Full recovery was also faster with embolization (12.1 days vs. 24.2 days). However, short-term complications were comparable at 18% for each cohort.

Post-30-day results were available for 44 embolization patients and 49 myomectomy patients who had been followed for an average of 19 months.

Dr. Mara noted that both groups showed technical success and symptom relief in more than 90% of study patients.

Although late complications were slightly higher with embolization, the difference was not significant.

Trial participants were allowed to attempt conception 6 months after their respective procedures.

“Unfortunately, the numbers of pregnant patients are quite low,” Dr. Mara said.

He and his collaborators reported five abortions and one termination in the embolization cohort.

There were four abortions in the myomectomy group, which also had one ectopic pregnancy.

Nine births were by cesarean section, which was elective in most cases, according to Dr. Mara.

At the time of his presentation, two of the women from the embolization group and five of the women from the myomectomy group were pregnant.

Dr. Mara began his discussion with an anecdote tracing his decision to initiate the trial to his experience with a patient who had aborted twins because of fibroids.

He recalled seeking advice from his colleagues on how to treat the woman, as she had still hoped to bear a child.

“I asked five of them, and I received five different recommendations,” on how to treat the patient, Dr. Mara said.

“From the point of view of the gynecologist, if you want to treat fibroids, this is crucial—the desire of women to get pregnant,” he added.

NICE, FRANCE — Preliminary results from a prospective randomized trial in the Czech Republic show more women of reproductive age becoming pregnant after myomectomy than after uterine fibroid embolization.

Ten pregnancies were reported among 18 women who tried to conceive after uterine fibroid embolization (UFE). Twenty pregnancies occurred among 30 patients who sought to become pregnant after myomectomy.

So far, two babies have been born to mothers who had embolization, and 10 babies have been born to mothers who underwent myomectomy.

The investigators have declined to draw conclusions on outcomes at this point, however, because the number of women attempting pregnancy after embolization was relatively small.

“In terms of fertility, these are preliminary results. We draw no conclusion at the moment in terms of outcomes,” investigator Michal Mara, M.D., Ph.D., told this newspaper after she presented data at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe.

“I think in the group with UFE, there were fewer patients trying to conceive at the moment. It was too small,” he said, adopting a watch-and-wait approach for the ongoing study.

The trial randomized 49 women to embolization and 56 to myomectomy (33 laparoscopic procedures and 23 open myomectomies were performed).

Both groups had an average age of 32 years, a mean of two fibroids per patient, as well as “a negative reproductive history,” according to Dr. Mara, who is in the department of obstetrics and gynecology at Charles University in Prague.

Fewer than half the women in either group had ever been pregnant, and roughly three-fourths had not delivered a baby. Infertility was reported in 11 embolization patients and in 26 women in the myomectomy group.

Hospital stays were significantly shorter with embolization (3.6 days vs. 4.7 days with myomectomy). Full recovery was also faster with embolization (12.1 days vs. 24.2 days). However, short-term complications were comparable at 18% for each cohort.

Post-30-day results were available for 44 embolization patients and 49 myomectomy patients who had been followed for an average of 19 months.

Dr. Mara noted that both groups showed technical success and symptom relief in more than 90% of study patients.

Although late complications were slightly higher with embolization, the difference was not significant.

Trial participants were allowed to attempt conception 6 months after their respective procedures.

“Unfortunately, the numbers of pregnant patients are quite low,” Dr. Mara said.

He and his collaborators reported five abortions and one termination in the embolization cohort.

There were four abortions in the myomectomy group, which also had one ectopic pregnancy.

Nine births were by cesarean section, which was elective in most cases, according to Dr. Mara.

At the time of his presentation, two of the women from the embolization group and five of the women from the myomectomy group were pregnant.

Dr. Mara began his discussion with an anecdote tracing his decision to initiate the trial to his experience with a patient who had aborted twins because of fibroids.

He recalled seeking advice from his colleagues on how to treat the woman, as she had still hoped to bear a child.

“I asked five of them, and I received five different recommendations,” on how to treat the patient, Dr. Mara said.

“From the point of view of the gynecologist, if you want to treat fibroids, this is crucial—the desire of women to get pregnant,” he added.