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

Phase 3

Completed

• Conditions: Poor Responder to IVF Treatment; Infertility
• Interventions: Dietary Supplement: Dehydroepiandrosterone

• Registration Number: NCT01535872
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Primary Completion: 2014-10
• Study Completion: 2017-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-08-05
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHEA treatment	Dehydroepiandrosterone	-

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	About one month after embryo transfer

Secondary Outcome Measures

Name	Time	Method
Quality of embryos at the end of IVF treatment	Within 3 weeks after ovarian stimulation
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
Oocyte quality	Within 3 weeks after ovarian stimulation
Number of embryos	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

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore