Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients
This study is currently recruiting participants.
Verified April 2013 by KK Women's and Children's Hospital
Sponsor:
KK Women's and Children's Hospital
Information provided by (Responsible Party):
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT01535872
First received: February 15, 2012
Last updated: April 8, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Infertility
Drug Information available for:
Prasterone
U.S. FDA Resources
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: | February 2014 |
| Estimated Primary Completion Date: | January 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
- Conduct a prospective 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535872
Locations
| Singapore | |
| KK Women's and Children's Hospital | Recruiting |
| Singapore, Singapore, 229899 | |
| Contact: Xiang Wen Ng, BSc +65-63941215 Ng.Xiang.Wen@kkh.com.sg | |
| Contact: Charmaine Khoo, MSc +65-63941215 Charmaine.Ann.Khoo.SL@kkh.com.sg | |
| Principal Investigator: Veronique Viardot-Foucault, MD, FAMS (Endocrinology) | |
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: | April 8, 2013 |
| 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 May 22, 2013