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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT01535872
First received: February 15, 2012
Last updated: May 8, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Infertility
Poor Responder to IVF Treatment
Dietary Supplement: Dehydroepiandrosterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by KK Women's and Children's Hospital:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: About one month after embryo transfer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of oocytes retrieved at oocyte pick-up (OPU) [ Time Frame: Within 3 weeks after ovarian stimulation ] [ Designated as safety issue: No ]
  • Oocyte quality [ Time Frame: Within 3 weeks after ovarian stimulation ] [ Designated as safety issue: No ]
  • Number of embryos [ Time Frame: Within 3 weeks after ovarian stimulation ] [ Designated as safety issue: No ]
  • Quality of embryos at the end of IVF treatment [ Time Frame: Within 3 weeks after ovarian stimulation ] [ Designated as safety issue: No ]
  • The markers of ovarian reserves (AMH, FSH, AFC) at the end of DHEA treatment [ Time Frame: 4 - 5 months after DHEA treatment ] [ Designated as safety issue: No ]
  • Ovarian follicular levels of estradiol, testosterone, DHEA and IGF-1 at the time of OPU [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHEA treatment Dietary Supplement: Dehydroepiandrosterone
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
No Intervention: No treatment

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 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.
  Eligibility

Ages Eligible for Study:   21 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535872

Locations
Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
Principal Investigator: Veronique Viardot-Foucault, MD, FAMS (Endocrinology) KK Women's and Children's Hospital
  More Information

No publications provided

Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT01535872     History of Changes
Other Study ID Numbers: KSHFCTG34/10, SHF/CTG034/2010
Study First Received: February 15, 2012
Last Updated: May 8, 2014
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014