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

Primary Purpose

Infertility, Poor Responder to IVF Treatment

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Dehydroepiandrosterone
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

21 Years - 42 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DHEA treatment

No treatment

Arm Description

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Secondary Outcome Measures

The number of oocytes retrieved at oocyte pick-up (OPU)
Oocyte quality
Number of embryos
Quality of embryos at the end of IVF treatment
The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment
Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU

Full Information

First Posted
February 15, 2012
Last Updated
August 5, 2018
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01535872
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Poor Responder to IVF Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHEA treatment
Arm Type
Experimental
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Dehydroepiandrosterone
Intervention Description
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
About one month after embryo transfer
Secondary Outcome Measure Information:
Title
The number of oocytes retrieved at oocyte pick-up (OPU)
Time Frame
Within 3 weeks after ovarian stimulation
Title
Oocyte quality
Time Frame
Within 3 weeks after ovarian stimulation
Title
Number of embryos
Time Frame
Within 3 weeks after ovarian stimulation
Title
Quality of embryos at the end of IVF treatment
Time Frame
Within 3 weeks after ovarian stimulation
Title
The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment
Time Frame
4 - 5 months after DHEA treatment
Title
Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU
Time Frame
1-2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique Viardot-Foucault, MD, FAMS (Endocrinology)
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

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

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