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Efficacy of dehydroepiandrosterone (DHEA) to overcome the effect of ovarian ageing (DITTO): a proof of principle double blinded randomized placebo controlled trial

Narkwichean, Amarin; Maalouf, Walid E.; Baumgarten, Miriam; Polanski, Lukasz; Raine-Fenning, Nick; Campbell, Bruce K.; Jayaprakasan, Kannamannadiar

Authors

Amarin Narkwichean mzxan@nottingham.ac.uk

Walid E. Maalouf

Miriam Baumgarten miriam.baumgarten@nottingham.ac.uk

Lukasz Polanski lukasz.polanski@nottingham.ac.uk

Nick Raine-Fenning

Bruce K. Campbell bruce.campbell@nottingham.ac.uk

Kannamannadiar Jayaprakasan k.jayaprakasan@nottingham.ac.uk



Abstract

Objective: To evaluate the effect of DHEA supplementation on In-Vitro Fertilisation (IVF) outcome as assessed by ovarian response, oocyte developmental competence and live birth rates in women predicted to have poor ovarian reserve (OR). The feasibility of conducting a large trial is also assessed by evaluating the recruitment rates and compliance of the recruited participants with DHEA/placebo intake and follow-up rates.
Study design: A single centre, double blinded, placebo controlled, randomized trial was performed over two years with 60 women undergoing in-vitro fertilisation (IVF). 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 recruited. They were randomised to receive DHEA 75 mg/day or placebo for at-least 12 weeks before starting ovarian stimulation. They had long protocol using hMG 300 IU/day. Data analysed by “intention to treat”. Ovarian response, live birth rates and molecular markers of oocyte quality were compared between the study and control groups.
Results: The recruitment rate was 39% (60/154). A total of 52 participants (27 versus 25 in the study and placebo groups) were included in the final analysis after excluding eight. While the mean (standard deviation) DHEA levels were similar at recruitment (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.
Conclusion: 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 during IVF treatment with long protocol in women predicted to have poor OR.

Journal Article Type Article
Publication Date Nov 1, 2017
Journal European Journal of Obstetrics & Gynecology and Reproductive Biology
Electronic ISSN 0301-2115
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 218
APA6 Citation Narkwichean, A., Maalouf, W. E., Baumgarten, M., Polanski, L., Raine-Fenning, N., Campbell, B. K., & Jayaprakasan, K. (2017). 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 and Gynecology and Reproductive Biology, 218, doi:10.1016/j.ejogrb.2017.09.006. ISSN 0301-2115
DOI https://doi.org/10.1016/j.ejogrb.2017.09.006
Keywords IVF, ICSI, RCT, Poor Ovarian Reserve, Infertility, DHEA, In-vitro fertilisation, Low ovarian reserve, Poor responders, randomised controlled trial
Publisher URL http://www.sciencedirect.com/science/article/pii/S0301211517304281?via%3Dihub
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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