A Randomized Controlled Study of Human Serum Albumin and Serum Substitute Supplement as Protein Supplements for IVF Culture and the Effect on Live Birth Rates

Purpose: The purpose of this comparison is to determine the best of two protein sources in the embryo culture media for future use in the Presbyterian Assisted Reproductive Technology Services (ARTS) Program.

Background: For embryos to grow in the incubator, a protein source is essential in the embryo culture media. Currently, HSA (simple protein) is used as the sole protein source in the embryo culture media of the Presbyterian ARTS laboratories. Literature suggests that by adding globulins, e.g. SSS (increasing the complexity of the protein source) to the culture media, the resultant embryos may be of better quality and have an increased chance to produce a pregnancy. HSA and/or SSS are routinely used as a standard protein source by most commercial human IVF programs. Both sources of proteins are FDA approved for use in human embryo culture media. The goal is to switch to the better protein source (existing HSA vs. more complex SSS), without compromising established pregnancy rates. To do this responsibly, Presbyterian ARTS Program feels that it should introduce the potential improved formulation (existing culture media supplemented with SSS) by comparing it in a randomized, prospective way with the existing culture system (existing culture media supplemented with HSA).

Project Summary: Study design: The study will be conducted in a prospective, randomized way. Two treatment groups are considered: 1) culture media supplemented with HSA 2) Culture media supplemented with SSS. To allow for the well-documented decline in pregnancy rates with increased age, patients will be randomized within 4 age groups and 7 physicians within each treatment (blocked for age and physician within treatments). The age groups are: donor eggs; <35 years; 35 to 37 years; and 38 to 40 years as determined on the day of egg retrieval.

Endpoints Measured: The endpoints measured will be embryo cryopreservation-biochemical pregnancy-, clinical pregnancy-, ongoing pregnancy-, live birth- and embryo implantation rates.

Number of Patients in the Study: To detect a difference of 10% in pregnancy rates, 150 patients should be included in each treatment group. With the current patient volume, it should take less than one year to complete the study. Differences in implantation rates may be detected earlier (more embryos transferred than patients enrolled). Should significance differences in pregnancy rates become evident before the full number of patients is enrolled, the study may be terminated.