Immunotherapy for Recurrent Miscarriage

The Ethics Committee of the American Society of Reproductive Immunology generated a worldwide, retrospective, collaborative, observational study and meta-analysis to address the question of effectiveness of allogeneic mononuclear cell immunization treatment for unexplained recurrent miscarriages (1-4). After the data on individual patients in studies from various centers around the world were collected, the information was analyzed independently by two teams. A Consensus Conference was held in Washington, DC, July 16-17,1993, to enable the contributors of the data to discuss the result of the two independent analyses. Three independent observers were present at the Consensus Conference: Dr. Norbert Gleicher and Dr. John Herr (from the Executive Council of the American Society of Reproductive Immunology), and Dr. James Schlesselman, an independent statistician/epidemiologist selected by Dr. Herr. A consensus was reached, and a manuscript prepared and circulated to data submittors and to the ASRI Council for comments. After submission for publication, peer review, and revision in response to referees' comments, the paper was accepted and published. S This issue of AJRI contains the proceedings from the Consensus Conference. The one and one-half-day program was divided into three parts, each lasting one-half day. The first part of the program consisted of short presentations from each contributor. Each was required to submit a four-page (four-slide) summary describing the patient population (inclusion/exclusion criteria, etc.), study design and methods, results of the trial, and any complications encountered. This data is included in the first section of this issue of AJR!. Information on method of randomization and blinding was validated by Dr. Jim Scott, who headed one of the analysis teams, and a summary of this information is included; a more detailed report can be found in." The second section of this issue gives the result of the two analysis teams. A summary of some of their results has been published elsewhere.' with updating/revision (analysis #2) based on some new information that came out at the Consensus Conference. The third section includes papers presented at the meeting describing possible alternative methods to allogeneic mononuclear cell immunization for immunotherapy of recurrent miscarriage. As a result of this work, we now have some data for guidance in clinical decision making with patients. The benefit of treatment, expressed as an increased likelihood of a live birth, appears small but significant and is greater than likelihood of a side effect of treatment. The magnitude of improvement is small, and this translates into a "number needed to treat" (NNT) to achieve one additional live birth in 11. The confidence interval for the NNT estiCAROLYN B. COULAM Genetics and IVF Institute, Fairfax, VA