NCT01572025

Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: Female
• Age: 23 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

* 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

Detailed description

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.

Conditions

• Infertility
• Ovarian Aging
• Diminished Ovarian Reserve (DOR)
• Predicted Poor-responders

Interventions

Type	Name	Description
DRUG	Dehydroepiandrosterone	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)
DRUG	Placebo	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)

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-04-05
• Last updated: 2015-12-09

Locations

1 site across 1 country: United Kingdom