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Trial record 21 of 235 for:    PRASTERONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535872
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertility Poor Responder to IVF Treatment Dietary Supplement: Dehydroepiandrosterone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.
Study Start Date : February 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: About one month after embryo transfer ]

Secondary Outcome Measures :
  1. The number of oocytes retrieved at oocyte pick-up (OPU) [ Time Frame: Within 3 weeks after ovarian stimulation ]
  2. Oocyte quality [ Time Frame: Within 3 weeks after ovarian stimulation ]
  3. Number of embryos [ Time Frame: Within 3 weeks after ovarian stimulation ]
  4. Quality of embryos at the end of IVF treatment [ Time Frame: Within 3 weeks after ovarian stimulation ]
  5. 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 ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535872

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

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Responsible Party: KK Women's and Children's Hospital Identifier: NCT01535872     History of Changes
Other Study ID Numbers: KSHFCTG34/10
SHF/CTG034/2010 ( Other Grant/Funding Number: SingHealth Foundation )
First Posted: February 20, 2012    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs