Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients
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|ClinicalTrials.gov Identifier: NCT01535872|
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility Poor Responder to IVF Treatment||Dietary Supplement: Dehydroepiandrosterone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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|
- Clinical pregnancy rate [ Time Frame: About one month after embryo transfer ]
- The number of oocytes retrieved at oocyte pick-up (OPU) [ Time Frame: Within 3 weeks after ovarian stimulation ]
- Oocyte quality [ Time Frame: Within 3 weeks after ovarian stimulation ]
- Number of embryos [ Time Frame: Within 3 weeks after ovarian stimulation ]
- Quality of embryos at the end of IVF treatment [ Time Frame: Within 3 weeks after ovarian stimulation ]
- 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 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01535872
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Veronique Viardot-Foucault, MD, FAMS (Endocrinology)||KK Women's and Children's Hospital|