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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Poor Responder to IVF Treatment
• Intervention / Treatment: Dietary supplement: Dehydroepiandrosterone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 42 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No treatment
EXPERIMENTAL: DHEA treatment	Dietary supplement: Dehydroepiandrosterone; DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Veronique Viardot-Foucault, MD, FAMS (Endocrinology), KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (ESTIMATE): February 20, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: KSHFCTG34/10; SHF/CTG034/2010 (OTHER_GRANT: SingHealth Foundation)