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In IVF-ET cycles—

 

Efficacy Comparable to IM Progesterone Across Age Groups1

 

Study design: Results of a prospective study with historical controls of 206 women receiving progesterone for an IVF-ET cycle; less than one third of patients also underwent ICSI. Patients eligible for the study received Crinone 8% (90 mg QD) starting on the evening of oocyte retrieval. Patients in the historical control group received IM progesterone (50 mg QD) starting on the evening of oocyte retrieval.
  • This study demonstrates comparable efficacy despite age (in the <35 y and 35–39 y age groups)
  • There are too few subjects >39 y to evaluate that age group

Proven pregnancy outcomes despite lower midluteal serum progesterone levels

  • Crinone 8%: 57.7 ± 7.4 ng/mL versus IM progesterone: 94.3 ± 8.8 ng/mL (P=.0015)

Reference: 1. Chantilis SJ, Zeitoun KM, Patel SI, et al. Use of Crinone vaginal progesterone gel for luteal support in in vitro fertilization cycles. Fertil Steril. 1999;72:823–829.

 

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.