This trial is active, not recruiting.

Conditions infertility, poor responder to ivf treatment
Treatment dehydroepiandrosterone
Phase phase 3
Sponsor KK Women's and Children's Hospital
Start date February 2012
End date October 2014
Trial size 280 participants
Trial identifier NCT01535872, KSHFCTG34/10, SHF/CTG034/2010


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
(No Intervention)

Primary Outcomes

Clinical pregnancy rate
time frame: About one month after embryo transfer

Secondary Outcomes

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

Eligibility Criteria

Female participants from 21 years up to 42 years old.

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

Additional Information

Official title Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.
Principal investigator Veronique Viardot-Foucault, MD, FAMS (Endocrinology)
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by KK Women's and Children's Hospital.