A proof of principle randomized controlled trial protocol

Researchers at the University of Nottingham are examining how dehydroepiandrosterone (DHEA) impacts pregnancy rates in women with diminished ovarian reserve.

Although the pilot study has a small sampling size of only 60 participants, researchers hopes to further understanding of DHEA’s improvement of pregnancy results in women undergoing in vitro fertilization treatments.

The paper was published online in the October 2014 issue of BMJ Open.

The study is a double-blind randomized controlled trial that will measure the effect of DHEA supplementation prior to and during controlled ovarian hyperstimulation on ovarian response prior to IVF treatment in women who are exhibiting poor ovarian reserve.

Pregnancy will be defined as urine pregnancy positive tests and 6 to 8 week ultrasound scans with fetal heart beat and live birth. Molecular and nutritional fingerprint analysis will be conducted in batches after finishing the clinical phase of the study.

http://bmjopen.bmj.com/content/4/10/e005767