OBJECTIVE

To determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and intrauterine insemination (IUI) cycles with gonadotropins in couples with unexplained infertility.

DESIGN

Prospective randomized controlled trial.

SETTING

University-based infertility clinic.

PATIENT(S): Two hundred fourteen couples with unexplained infertility who were treated during 427 ovarian stimulation and IUI cycles with recombinant FSH.

INTERVENTION(S): Patients underwent ovarian stimulation with recombinant FSH combined with IUI. Patients randomized into the study group (n = 109) received luteal phase support in the form of vaginal progesterone gel (Crinone 8% gel). Patients randomized into the control group (n = 105) received no luteal phase support.

MAIN OUTCOME MEASURE(S): Clinical pregnancy and live birth rate per cycle and per patient.

RESULT(S): Demographic data were found to be homogeneous between the study and control groups. Clinical pregnancy rates per cycle and per patient were significantly higher in the study group (21.1% and 39.4%, respectively) compared with the control group (12.7% and 23.8%, respectively). Live birth rate per cycle and per patient was also significantly higher in patients with luteal support (17.4% and 35.8%, respectively) compared with control subjects (9.3% and 18.1%, respectively).

CONCLUSION(S): Luteal phase support with vaginal progesterone gel significantly affects the success of ovarian stimulation and IUI cycles in patients with unexplained infertility.