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In IVF-ET cycles—

 

Comparable Pregnancy Rates Versus IM Progesterone1

 

Interim results from the largest prospective, randomized, controlled trial of Crinone 8% and IM progesterone

 

Study design: Results of a prospective, randomized trial of 215 women younger than 40 years receiving progesterone for an IVF-ET cycle. Patients were randomized to receive Crinone 8% (90 mg QD, starting 48 hours after oocyte retrieval) or IM progesterone (50 mg QD, starting 24 hours after oocyte retrieval). All patients with a positive pregnancy test in both groups received Crinone 8% until 10 weeks’ gestation.

 

No significant difference in ongoing pregnancy or miscarriage rates despite greater bleeding with Crinone 8%

  • Early spontaneous abortion: 28.6% (Crinone 8%) versus 26.1% (IM progesterone), P=NS
  • Vaginal bleeding between oocyte retrieval and pregnancy test: 42% (Crinone 8%) versus 27% (IM progesterone), P=.02

Reference: 1. Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein MD. Comparison of Crinone 8% intravaginal gel and intramuscular progesterone supplementation for in vitro fertilization/embryo transfer in women under age 40: interim analysis of a prospective randomized trial. Fertil Steril. 2008;89:485–487.

 

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.