DHEA Supplementation for Low Ovarian Response IVF Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00549081
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 24, 2007
October 24, 2007
January 2008
Not Provided
number of oocytes retrieved
Same as current
No Changes Posted
pregnancy rate delivery rate maximal serum estradiol levels ovarian reserve measures
Same as current
Not Provided
Not Provided
 
DHEA Supplementation for Low Ovarian Response IVF Patients
Not Provided

Approximately 10% of all couples will be diagnosed as infertile. The most efficient infertility treatment is In-Vitro Fertilization (IVF). One major determinant for success is production of an adequate number of oocytes (eggs) from the female in order to finally have good-quality embryos and finally acceptable pregnancy and delivery rates. Some women will not respond adequately to hormonal stimulation and will only a small number of oocytes. Therefore, the chances of finally having a successful delivery are significantly reduced. Although the specific definition of this situation is controversial, these patients are diagnosed as having "low ovarian response". This condition is more prevalent in older IVF patients as part of the reproductive aging process; it is possible at any age. Currently, the understanding of "low ovarian response" is limited, and although many therapeutic approaches have been suggested, no treatment has been proven significantly efficient.

DHEA is a pro-hormone produced by the adrenal gland and the ovary. DHEA serum levels become lower with age and in some chronic diseases. Therefore, some believe it may be beneficial as an 'anti-aging' factor. DHEA pills are available as a food-supplement, without need for prescription in the US.

DHEA is involved in the regulation of follicular growth in the ovaries. In a 2000 report, five IVF patients who had low ovarian response were treated with oral DHEA (Casson et al, Hum Reprod 2000;15:2129). A small increase in the ovarian response to hormonal stimulation was noticed. Barad and Gleicher reported their relatively extensive experience, summarizing treatment outcome in 25 IVF low-responders treated with oral DHEA pills (Barad and Gleicher, Hum Reprod 2006; 21, 2845). They observed increased increases in fertilized oocytes, normal day 3 embryos, and number of embryos transferred after DHEA treatment compared with a previous treatment outcome before DHEA.

Based on this observation, DHEA may appear useful for improving IVF outcome in some patients. However, a prospective randomized study on DHEA supplementation for IVF patients was not yet published. Our aim is to conduct such a study, focusing on IVF patient with low ovarian response.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility, Female
  • In-Vitro Fertilization
Dietary Supplement: DHEA
oral DHEA tablets 75 mg daily
  • Experimental: 1
    IVF patients who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.
    Intervention: Dietary Supplement: DHEA
  • No Intervention: 2
    IVF patient who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.
Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. Epub 2006 Sep 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
December 2008
Not Provided

Inclusion Criteria:

  • IVF patient
  • Low ovarian response to hormonal stimulation

Exclusion Criteria:

  • Previous DHEA supplementation
  • History of malignant disease
  • Liver dysfunction
  • Coagulation tendency
Female
18 Years to 43 Years
No
Contact: Avi Tsafrir, MD +972-2-666211 avits@scmz.org.il
Not Provided
 
NCT00549081
DHEA for LR in IVF.CTIL
No
Not Provided
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Ofer Gonen Meir Hospital, Sapir Medical Center, Kefar-Saba, Israel
Shaare Zedek Medical Center
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP