Clinical trial NCT01535872: Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients
Official title: Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Poor Responder to IVF Treatment
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2012-02-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: About one month after embryo transfer
Secondary outcomes:
measure: The number of oocytes retrieved at oocyte pick-up (OPU)
timeFrame: Within 3 weeks after ovarian stimulation
measure: Oocyte quality
timeFrame: Within 3 weeks after ovarian stimulation
measure: Number of embryos
timeFrame: Within 3 weeks after ovarian stimulation
measure: Quality of embryos at the end of IVF treatment
timeFrame: Within 3 weeks after ovarian stimulation
measure: The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment
timeFrame: 4 - 5 months after DHEA treatment
measure: Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Veronique Viardot-Foucault, MD, FAMS (Endocrinology)
role: PRINCIPAL_INVESTIGATOR
References: