In IVF-ET/ICSI cycles—

Pregnancy Rates Comparable To Vaginally Administered Capsules With Significantly Less Discomfort¹

Study design: Results of a prospective, randomized trial of 126 women receiving progesterone for IVF-ET or ICSI cycles. Patients received Crinone 8% (90 mg QD) or progesterone capsules used vaginally (200 mg TID). In both groups, progesterone support began on the evening before embryo transfer and continued until menstrual bleeding occurred or there was a positive pregnancy test. Patients who became pregnant received Gravibinon® (2 mL IM [250 mg 17OHP + 5 mg estradiol valerate]) BIW for 10 additional weeks or until an abortion occurred. Patient preference data (mean scores) are derived from a questionnaire asking 47 randomly selected nonpregnant patients about aspects of comfort during luteal phase support after IVF-ET or ICSI cycles.

Utrogest® is manufactured by Dr. Kade Pharmazeutische Fabrik GmbH. This product is marketed in the United States by Solvay Pharmaceuticals, Inc., as Prometrium®.

Gravibinon is a registered trademark of Schering AG.

Reference: 1. Ludwig M, Schwartz P, Babahan B, et al. Luteal phase support using either Crinone® 8% or Utrogest®: results of a prospective, randomized study. Eur J Obstet Gynecol Reprod Biol. 2002;103:48–52.

Important Safety Information

The most common side effects of CRINONE (progesterone gel) 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active, or a history of, thrombophlebitis or thromboembolic disorders, patients who have known sensitivity to CRINONE 8%, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. Should any of the earliest manifestations of thrombotic disorders occur, the drug should be discontinued immediately. No adequate evidence is available to show that progesterone and progestins are effective in preventing miscarriage in women with a history of recurrent spontaneous pregnancy losses. The pretreatment physical exam should include special reference to breast and pelvic organs as well as a Papanicolaou smear. Nonfunctional causes of breakthrough bleeding should be considered, and for undiagnosed vaginal bleeding, diagnostic measures should be undertaken. Special care should be taken with patients who have conditions that may be influenced by fluid retention, those who have a history of psychic depression, and those with diabetes.