Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients
|Infertility Poor Responder to IVF Treatment||Dietary Supplement: Dehydroepiandrosterone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.|
- Clinical pregnancy rate [ Time Frame: About one month after embryo transfer ]
- The number of oocytes retrieved at oocyte pick-up (OPU) [ Time Frame: Within 3 weeks after ovarian stimulation ]
- Oocyte quality [ Time Frame: Within 3 weeks after ovarian stimulation ]
- Number of embryos [ Time Frame: Within 3 weeks after ovarian stimulation ]
- Quality of embryos at the end of IVF treatment [ Time Frame: Within 3 weeks after ovarian stimulation ]
- The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment [ Time Frame: 4 - 5 months after DHEA treatment ]
- Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU [ Time Frame: 1-2 years ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2017|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: DHEA treatment||
Dietary Supplement: Dehydroepiandrosterone
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
|No Intervention: No treatment|
Poor responders to IVF treatment occurs in 5-24% of in-vitro fertilisation (IVF) cycles, resulting in the cancellation of the cycle translating in very low pregnancy rate. Current interventions based upon the use of different stimulation regimen do not address the fundamental underlying physiological basis of follicular recruitment and development.
The over-riding objective of this proposal is to devise novel therapeutic approaches to the treatment of poor responders of IVF treatment through dietary supplementation with Dehydroepiandrosterone (DHEA). The investigators hypothesise that DHEA supplementation leads to improvements in ovarian steroidogenesis in poor responders, leading to improved IVF outcome. Specifically, the investigators aim to
- Conduct a prospective randomised controlled trial (RCT) on the effects of DHEA supplementation in women who are poor responders to IVF treatment.
- Investigate the effects of DHEA supplementation on ovarian steroidogenesis and biochemical and ultrasonographic markers of ovarian reserves.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535872
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Veronique Viardot-Foucault, MD, FAMS (Endocrinology)||KK Women's and Children's Hospital|