EARLY-PREG: A Preconception, Longitudinal, Bidirectional, and Counterfactual Cohort Study of Women Seeking Pregnancy, Designed to Investigate Maternal-Embryonic Molecular Interactions During the Peri-implantation Window

What this Trial Is About

Researchers are investigating how the early embryo and mother communicate at the molecular level during the critical first two weeks after fertilization. This observational study follows healthy women, some seeking pregnancy and others not, to understand the biological signals involved in embryo implantation and early pregnancy. The study aims to characterize these interactions in natural human conception, addressing gaps left by animal and lab studies. Participants provide daily biological samples such as saliva, urine, blood, cervicovaginal fluid, and brushings during key menstrual cycle phases. The study distinguishes between conception cycles—when fertilization and pregnancy occur, confirmed by positive beta-hCG tests—and non-conception cycles without pregnancy, serving as counterfactual comparisons. Samples are stored in a biorepository for detailed molecular analysis. Women are followed for up to six menstrual cycles or until pregnancy occurs, with outcomes including full-term pregnancies, early pregnancy losses (miscarriages up to 12 weeks), and cycles without conception. Researchers assess these outcomes using blood beta-hCG levels. Throughout participation, women undergo clinical evaluations and sample collections to monitor maternal-embryonic molecular interactions, enhancing understanding of early pregnancy and childbirth processes.

EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions