NOTICE OF INTENT TO SOLE SOURCE

The study, A Girls First Period (IRB Protocol 19-E-0110), aims to obtain a better understanding of normal hormonal dynamics during the transition from menarche to the establishment of mature ovulatory cycles – a prerequisite for fertility. The study began in 2019 and is expected to complete in 2029. Over the last 5 years, 78 participants have enrolled towards the 350-accrual goal.

A vendor is needed to perform comprehensive laboratory services for this study, including testing hormones from minimal samples collected from participants enrolled over the next 3 years. The study utilizes dried urine and dried blood spot cards, ultimately benefiting the study participant because they are minimally invasive and require a smaller collection of a blood or urine specimen. A smaller collection also provides better utilization of care for the participant.

In addition, the cards are easily stored and transported. The vendor is expected to accurately extract and analyze hormones in dried blood spots and dried urine cards from both pediatric and adult participants.