* To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment. * To evaluate the feasibility of conducting a large multicentre trial
The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers. This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Dehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)
Matched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)
Nottingham University Research and Treatment Unit in Reproduction (NURTURE)
Nottingham, Nottinghamshire, United Kingdom
Number of oocytes retrieved
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
Time frame: within 15 weeks after DHEA/Placebo supplementation
Feasibility to conduct a large multicentre randomised controlled trial
Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates
Time frame: with in 20 weeks of the research period (per participant)
Oocyte quality (clinical and molecular markers)
Clinical pregnancy rates (Pregnancy rate determined at week 5 to 7 after embryo transfer). Molecular markers of oocyte quality as assessed by expression of cumulus cell molecular markers of oocyte competence and also by assessing energy consumption (pyruvate, lactate and glucose utilization) from the media by the oocytes and embryos (nutritional finger printing)
Time frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology
Time frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
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