Conference Coverage
MUNICH – Routine hysteroscopy and treatment of uterine abnormalities found by using it failed to improve the live-birth rate after in vitro fertilization in asymptomatic women with no ultrasound findings who already had failed two to four attempts at pregnancy and delivery with IVF, in a randomized, controlled trial of 656 women.
"Out-patient hysteroscopy cannot be routinely recommended after recurrent in vitro fertilization failure," concluded Dr. Tarek El-Toukhy at the annual meeting of the European Society of Human Reproduction and Embryology.
Mitchel L. Zoler/Frontline Medical News
Dr. Tarek El-Toukhy
Based on these findings, hysteroscopy should be limited to women with clinical symptoms or ultrasound findings that suggest an abnormality in the uterine cavity, but hysteroscopy should not be performed routinely in all women who have a history of multiple miscarriages, said Dr. El-Toukhy, a gynecologist at Guy’s and St. Thomas’ Hospital in London.
The study results indicated that roughly one in nine of the enrolled women had a uterine abnormality that was detectable by hysteroscopy, but finding and correcting these problems had no effect on pregnancy outcomes.
Seeing these data, "I have the impression that [routine hysteroscopy] is of no use. The study was well done," commented Dr. Klaus Friese, a gynecologist and director of the Women’s Hospital of the University of Munich.
"When you see something unusual by ultrasound or if you suspect a problem, then you should do hysteroscopy, but not just because the women had three miscarriages when the ultrasound shows nothing," Dr. Friese said in an interview.
The findings also suggest that when multiple miscarriages occur following IVF, embryo factors are often involved rather than issues in the mother, said Dr. El-Toukhy. "Even when women had a uterine issue, treatment did not help. That lends more importance to embryo factors. Uterine factors can be important, but not as important as embryo factors" to explain multiple miscarriages following IVF, he said.
The TROPHY (Trial of Outpatient Hysteroscopy) study was run at eight centers in four European countries. The investigators randomized women who were younger than 38 years and who had a body mass index of less than 35 kg/m2, a history of two to four prior miscarriages following IVF, and a normal-appearing uterus when assessed by transvaginal ultrasonography. Woman randomized to routine hysteroscopy had the procedure done using a Campo Trophyscope marketed by Karl Storz. Uterine abnormalities found by routine hysteroscopy were treated when appropriate. All women enrolled then underwent ovarian stimulation and IVF using usual local protocols.
At the end of the study, the 332 women randomized to routine hysteroscopy with evaluable follow-up had a 39% pregnancy rate and a 30% live-birth rate, not statistically different from the 39% pregnancy rate and 29% live-birth rate seen among 324 evaluable women randomized to no hysteroscopy, Dr. El-Toukhy reported.
In the women randomized to routine hysteroscopy, 11% showed a significant abnormality on examination, including 15 women with an arcuate uterus, 11 women with endometrial polyps, and five women with a partial septum, as well as women with a few other less common abnormalities. Fifteen women underwent a surgical procedure to address abnormalities found by hysteroscopy. Hysteroscopy also found one or more "subtle" abnormalities in 13% of the examined women, a category for abnormalities of uncertain significance that included hypervascularization of the uterus (20 women) and mucosal elevation (13 women). None of the subtle abnormalities received treatment.
Prespecified analyses of the outcomes in the subgroup of women who had routine hysteroscopy showed no statistically significant differences in the pregnancy or live-birth rates of the women with or without significant uterine abnormalities identified by hysteroscopy or in the women with or without subtle uterine abnormalities, Dr. El-Toukhy said.
Karl Storz supplied the hysteroscopy devices used in the study and training in their use. Dr. El-Toukhy said that he and his associates had no other disclosures. Dr. Friese had no relevant disclosures.
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