Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.

Conditions
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Infertility, Poor Responder to IVF Treatment

Intervention / Treatment
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* Dietary Supplement: Dehydroepiandrosterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHEA treatment<br> | Dietary Supplement: Dehydroepiandrosterone<br>* DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.<br>|
| No Intervention: No treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | About one month after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of oocytes retrieved at oocyte pick-up (OPU) |  | Within 3 weeks after ovarian stimulation | 
| Oocyte quality |  | Within 3 weeks after ovarian stimulation | 
| Number of embryos |  | Within 3 weeks after ovarian stimulation | 
| Quality of embryos at the end of IVF treatment |  | 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 | 
| Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU |  | 1-2 years |