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

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Infertility; Poor Responder to IVF Treatment

Treatments: Dietary Supplement: Dehydroepiandrosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01535872

SHF/CTG034/2010 (Other Grant/Funding Number)

KSHFCTG34/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 21 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DHEA treatment

Experimental group

Treatment:

Dietary Supplement: Dehydroepiandrosterone

No treatment

No Intervention group