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In donor egg cycles—

 

Comparable Pregnancy Outcomes Versus IM Progesterone in Women Without Endogenous Progesterone Production1

 

Study design: Results of a prospective, randomized trial in 72 women receiving progesterone for a donor egg cycle. All patients received estradiol and were randomized to receive Crinone 8% (90 mg BID) or IM progesterone (100 mg QD) in a 7:3 ratio, respectively. Crinone 8% was administered from the evening of cycle day 14 until negative pregnancy test for 2 weeks or for a total of 10 weeks in case of pregnancy; IM progesterone was administered from the evening of cycle day 15 until negative pregnancy test or for a total of 10 weeks in case of pregnancy (with dosage reduced to 50 mg QD in the 8th week).
  • Comparable implantation rates for Crinone 8% and IM progesterone (23% vs 18%, P=NS)
  • Comparable pregnancy rates despite lower serum progesterone levels for Crinone 8% versus IM progesterone
  • In-phase endometrial biopsies

Reference: 1. Gibbons WE, Toner JP, Hamacher P, Kolm P. Experience with a novel vaginal progesterone preparation in a donor oocyte program. Fertil Steril. 1998;69:96–101.

 

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.