Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins : a randomized multicenter study
Faculty of Medicine and Health Sciences
Publication type
Baltimore, Md ,
Human medicine
Source (journal)
Fertility and sterility. - Baltimore, Md
Target language
English (eng)
Full text (Publishers DOI)
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 R5 million after capacitation. Intervention(s): Gonadotropin stimulation, IUI, randomization to LPS using vaginal progesterone gel (n ¼ 202) or no LPS (n ¼ 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], 0.892.67). Similarly, the secondary outcome, the livebirth rate, was 14.9% in the treatment group and 9.4% in the control group (RR 1.60; 95% CI, 0.892.87). 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, 1.582.56). 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. (Fertil Steril 2016;-:--. 2016 by American Society for Reproductive Medicine.) Key Words: Duration luteal phase, intrauterine insemination, gonadotropin, luteal phase, MAR, randomized, progesterone, pregnancy rate