Efficacy of Dehydroepiandrosterone (DHEA) to overcome the effect of ovarian ageing (DITTO): A proof of principle double blinded Randomized placebo Controlled Trial
European Journal of Obstetrics & Gynecology and Reproductive Biology Sep 16, 2017
Narkwichean A, et al. - This study is performed to assess the impact of DHEA supplementation on In-Vitro Fertilisation (IVF) outcome as evaluated by the ovarian response, oocyte developmental competence and live birth rates in women predicted to have a poor ovarian reserve (OR). Pre-treatment DHEA supplementation, albeit statistical power in this study is low, did not improve the response to controlled ovarian hyperstimulation or oocyte quality or live birth rates amid IVF treatment with the long protocol in women predicted to have poor OR.
Methods
- For this study, they designed a single centre, double blinded, placebo controlled, randomized trial.
- This study was performed over two years.
- 60 women undergoing in-vitro fertilisation (IVF) were enrolled in this study.
- Subjects were randomized, based on a computer-generated pseudo-random code to receive either DHEA or placebo with both capsules having similar colour, size and appearance.
- 60 women with poor OR based on antral follicle count or anti-Mullerian hormone thresholds undergoing IVF were enlisted.
- They were randomised to receive DHEA 75 mg/day or placebo for at-least 12 weeks before starting ovarian stimulation.
- They had long protocol utilizing hMG 300 IU/day.
- Information investigated by Âintention to treatÂ.
- Ovarian response, live birth rates and molecular markers of oocyte quality were compared between the study and control groups.
Results
- In this study, 39% (60/154) was the recruitment rate.
- After excluding eight, a total of 52 participants (27 versus 25 in the study and placebo groups) were incorporated into the last examination.
- While the mean (standard deviation) DHEA levels were similar at enlistment (9.4 (5) versus 7.5 (2.4) ng/ml; P = 0.1), the DHEA levels at pre-stimulation were higher in the study group than in the controls (16.3 (5.8) versus 11.1 (4.5) ng/ml; P < 0.01).
- The number (median, range) of oocytes retrieved (4, 0-18 versus 4, 0-15 respectively; P = 0.54) and live birth rates (7/27, 26% versus 8/25, 32% respectively; RR (95% CI): 0.74 (0.22-2.48) and mRNA expression of developmental biomarkers in granulosa and cumulus cells were similar between the groups.
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