Fertility and sterility · 2016
Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Peeraer Karen, D'Hooghe Thomas, Laurent Pascale, Pelckmans Sofie, Delvigne Annick, Laenen Annouschka, Welkenhuysen Myriam, Wyns Christine, De Neubourg Diane
Аннотация
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.
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.