Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study.

OBJECTIVE

To evaluate the effect of luteal phase support (LPS) in intrauterine insemination (IUI) cycles stimulated with gonadotropins.

DESIGN

Randomized multicenter trial.

SETTING

Academic tertiary care centers and affiliated secondary care centers.

PATIENT(S): Three hundred and ninety-three normo-ovulatory patients, <43 years, with body mass index ≤30 kg/m2, in their first IUI cycle, with at least one patent tube, a normal uterine cavity, and a male partner with total motile sperm count ≥5 million after capacitation.

INTERVENTION(S): Gonadotropin stimulation, IUI, randomization to LPS using vaginal progesterone gel (n = 202) or no LPS (n = 191).

MAIN OUTCOME MEASURE(S): Clinical pregnancy rate, live-birth rate, miscarriage rate, and duration of the luteal phase.

RESULT(S): The primary outcome, the clinical pregnancy rate, was not statistically different between the treatment group (16.8%) and the control group (11%) (relative risk [RR] 1.54; 95% confidence interval [CI], 0.89-2.67). Similarly, the secondary outcome, the live-birth rate, was 14.9% in the treatment group and 9.4% in the control group (RR 1.60; 95% CI, 0.89-2.87). The mean duration of the luteal phase was about 2 days longer in the treatment group (16.6 ± 2.2 days) compared with the control group (14.6 ± 2.5 days) (mean difference 2.07; 95% CI, 1.58-2.56).

CONCLUSION(S): Although a trend toward a higher clinical pregnancy rate as well as live-birth rate was observed in the treatment group, the difference with the control group was not statistically significant.

CLINICAL TRIAL REGISTRATION NUMBER: NCT01826747.