Novel use of intrauterine instillation of Hyaluronan enriched media on clinical outcomes of intrauterine insemination treatment: a pilot randomized controlled trial.

OBJECTIVE

To study the effect of intrauterine instillation of Hyaluronan enriched media on reproductive outcomes of intrauterine insemination treatment.

DESIGN AND

PARTICIPANTS

100 couples with unexplained infertility were approached and were randomly allocated to the intervention and control arm with 1:1 allocation over 2 years of duration.

INTERVENTION AND OUTCOME MEASURES: The study participants received controlled ovarian stimulation and intrauterine insemination. Additionally, the intervention group, received intrauterine administration of Hyaluronan enriched media. The intervention group and control group was compared for clinical pregnancy, live birth and miscarriages using the SPSS statistical package (version 23.0).

RESULTS

The study observed a trend of improved cumulative biochemical pregnancy rates (33.3% Vs 15.5%, RR 2.14, 95% CI 0.96-4.75, p = 0.061) and clinical pregnancy rates (31.1% Vs 15.5%, RR 2.00, 95% CI 0.89-4.48, p = 0.093) in the intervention group, which however did not reach statistical significance. The cumulative live birth occurrence was statistically significantly better in the intervention arm (28.9% vs 11.1%). RR 2.60, 95% CI 1.01-6.89, p = 0.047) of the trial. Similar miscarriage rates were observed in both arms of the trial (4.4% Vs 4.4%, RR 1.0, 95% CI 0.15-6.79, p = 1.00). The intrauterine insemination instillation of hyaluronan enriched media was well tolerated by participants in the intervention arm.

CONCLUSIONS

The study suggests a potential benefit of use of hyaluronan enriched media as a novel minimally invasive add-on intervention to facilitate the enhancement of success rates of IUI treatment.