Infertility, Poor Responder to IVF Treatment
Conditions
Brief summary
The aim of this study is to show solid evidences of the efficacy of DHEA in improving the success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.
Detailed description
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 1. Conduct a prospective randomised controlled trial (RCT) on the effects of DHEA supplementation in women who are poor responders to IVF treatment. 2. Investigate the effects of DHEA supplementation on ovarian steroidogenesis and biochemical and ultrasonographic markers of ovarian reserves.
Interventions
DIETARY_SUPPLEMENTDehydroepiandrosterone
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* All women who meet one of the two following Bologna criteria for poor responder: an abnormal ovarian reserve test (AMH \<1.0 ng/mL or FSH \>10 IU/L ), or where fewer than 4 oocytes were retrieved or fewer than 4 follicles were observed in a previous IVF stimulation cycle with either standard long or antagonist protocols * Where informed consent can be obtained
Exclusion criteria
* Previous or current DHEA supplementation * Previous and current use of corticosteroids * Major systemic illnesses * Allergy to DHEA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate | About one month after embryo transfer |
Secondary
| Measure | Time frame |
|---|---|
| Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU | 1-2 years |
| The number of oocytes retrieved at oocyte pick-up (OPU) | Within 3 weeks after ovarian stimulation |
| The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment | 4 - 5 months after DHEA treatment |
| Number of embryos | Within 3 weeks after ovarian stimulation |
| Quality of embryos at the end of IVF treatment | Within 3 weeks after ovarian stimulation |
| Oocyte quality | Within 3 weeks after ovarian stimulation |
Countries
Singapore
Outcome results
None listed