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Luteal Support with Crinone 8% in 1827 Women Undergoing Assisted Reproductive Technology (ART) Procedures

2000; Elsevier BV; Volume: 74; Issue: 3 Linguagem: Inglês

10.1016/s0015-0282(00)01158-4

1556-5653

Hagai Levine,

Reproductive Health and Technologies

Objectives: To assess the ability to provide luteal support using the controlled and sustained release vaginal progesterone gel, Crinone 8%, in women undergoing ART procedures. Design: Interim analysis of an open-label, multi-center trial conducted in 23 US ART centers that performed fresh IVF-ET, fresh donor IVF-ET, and controlled ovarian hyperstimulation-intrauterine insemination (IUI). Materials and Methods: Participating centers were instructed to use Crinone according to their own criteria for starting and continuing luteal support in ART cycles. Patients administered Crinone 8% (Serono Laboratories, Randolph, MA) daily. All other pertinent steps in ART treatment remained unchanged in each center. Clinical pregnancy is defined as a positive pregnancy test during weeks 6–8 and a gestational sac observed on ultrasound. Ongoing pregnancy is defined by identifying a fetal heartbeat at week 20. In those centers which completed at least 40 fresh IVF-ET patients, retrospective analysis also compared the clinical pregnancy rates (per retrieval) between women in the current study versus the results of women who underwent this procedure in 1997, as reported to the Society for Assisted Reproductive Technologies (SART). Weighted means were used and statistical significance was assessed using unpaired t-tests. These 1997 data from the same participating centers in this study was calculated to exclude study patients. This interim analysis included results from 1827 women who had completed Crinone treatment through January 2000. Patients also evaluated Crinone acceptability via a questionnaire. Results: Tabled 1OutcomeFresh IVF-ET (n=1184)SART (1997) (n=4801)Fresh donor IVF (n=147)IUI (n=496)Clinical pregnancy (%)35.0533.4336.715.9Ongoing pregnancy (%)31.00N/A32.012.9 Open table in a new tab Conclusions: Mean clinical pregnancy rates following IVF-ET procedures which used Crinone are similar (p=0.29) to the data reported to SART (1997). Patients evaluated Crinone to be easier to use and preferable to IM progesterone, 94% and 84%, respectively. Overall results from 1827 women indicate that daily administration of Crinone 8% is an efficacious and well-received alternative to painful daily IM progesterone injections for luteal support in ART procedures.