DHEA Intervention To Treat Ovarian aging

• Research type

  Research Study

• Full title

  Efficacy of Dehydroepiandrosterone to overcome the effect of ovarian aging

• IRAS ID

  82190

• Contact name

  k jayaprakasan

• Eudract number

  2011-002425-21

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  One of the most striking trends in western societies in the last few decades is the postponement of childbearing mainly due to behavioral changes and consequently an increasing number of women are now seeking medical help because of involuntary childlessness. Furthermore, the reproductive health of women is increasingly being recognised as a sentinel for chronic diseases of later life. Loss of ovarian function can have other far-reaching clinical and psychological consequences on female health through effects on metabolism, cardiovascular function, cognition, response to stress, osteoporosis, increased risk of breast cancer and mortality. As the longevity of the human population increases, so the long-term health consequences of ovarian ageing achieve an increasing significance. This study is focused primarily on intervention using DHEA to counteract the effect of age-related decline in ovarian function, which can occur even in relatively young women. The findings in this study would therefore potentially have a significant and immediate impact on the treatment of infertility in women with aged ovaries and may also indicate further interventions designed to also extend reproductive longevity. Women undergoing IVF treatment provide an ideal group with whom we can evaluate the number and quality of eggs available within the ovaries. Women predicted to have aged ovaries based on ultrasound scan (antral follicle count of less than 10), blood test (anti-mullerian hormone <5 Pmol/L) or previous poor response during IVF treatment (=3 eggs collected) will be invited to take part in the study, which will be conducted at NURTURE. Those who wish to take part will be randomly allocated to receive either DHEA or placebo in this study, which aims to see if DHEA treatment before and during IVF/ICSI treatment (14-16 weeks treatment with DHEA in total) can increase the numbers of oocytes retrieved and ultimately improve the chances of pregnancy. This study also aims to explore the mechanism of action of DHEA on growth and development of follicles with in which egg lies, by utilizing the follicular fluid, cells and immature eggs obtained during egg collection and unfertilized eggs, which are otherwise routinely discarded and not used for treatment. The follicular fluid and cells will be assessed for various molecular markers of egg quality. The immature and unfertilised eggs will be assessed for any chromosomal abnormalities, which are one of the commonest reasons for unsuccessful IVF/ICSI treatment, particularly in predicted poor responders. Further, the data from this study will be useful to design and carry out a much larger international study to explore the benefit of DHEA not only in women having fertility problem and but also in women at risk of premature menopause. Each participant will spend about 16 to 20 weeks in the study depending on her treatment outcome. If not pregnant, the study will end on the day of pregnancy test (16th week), while pregnant subjects will have their pregnancy scan at 6 weeks of gestation (20th week). The total duration of a standard IVF/ICSI treatment (from commencement of their treatment to the day that they know their outcome) is 7 to 11 weeks.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0002

• Date of REC Opinion

  16 Jan 2012

• REC opinion

  Further Information Favourable Opinion