Effect of Premedication Hyoscine-N-Butylbromide before Hysterosalpingography for Diagnosis of Proximal Tubal Obstruction in Infertile Women: a Randomized Double-Blind Controlled Trial.

OBJECTIVE

To assess the effect of hyoscine-N-butylbromide (HBB) as premedication on the rate of proximal tubal obstruction during hysterosalpingography (HSG).

METHODS

A randomized, double-blind controlled trial (Canadian Task Force classification I).

METHODS

The Infertility Clinic of Songklanagarind Hospital.

METHODS

One hundred and forty-six infertile women indicated for HSG investigation.

METHODS

Patients were randomly assigned to receive either oral HBB 20 mg or placebo 30 minutes before the procedure between May 1, 2016 and March 31, 2017. If proximal tubal obstruction was found, participants would be assigned to undergo a second confirming HSG or laparoscopy with chromopertubation within 6 months.

RESULTS

The primary outcome was the rate of proximal tubal obstruction. The secondary outcome was the false positive result of proximal tubal occlusion from HSG. Proximal tubal obstruction was found in 6 of 70 and 16 of 71 in the HBB and placebo groups, respectively. The rate of proximal tubal obstruction in the HBB group was significantly lower than in the placebo group (8.6% vs. 22.5%, p = .04; absolute difference, 13.9%; 95% confidence interval [CI]: 0.02-0.26; relative risk [RR]: 0.38; 95% CI: 0.16-0.92). After the second HSG or laparoscopy was performed (n = 22), the HBB group revealed a false occlusion in 20% (1/6 patients), and the placebo group had a higher false occlusion in 69.2% (9/16 patients).

CONCLUSIONS

Premedication with HBB before HSG can reduce the rate of diagnosis of proximal tubal obstruction and false occlusion.