DHEA Supplementation for Low Ovarian Response IVF 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: NCT00549081
Recruitment Status : Unknown
Verified October 2007 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2007
Last Update Posted : October 25, 2007
Information provided by:
Shaare Zedek Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Infertility, Female In-Vitro Fertilization Dietary Supplement: DHEA Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
IVF patients who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.
Dietary Supplement: DHEA
oral DHEA tablets 75 mg daily

No Intervention: 2
IVF patient who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.

Primary Outcome Measures :
  1. number of oocytes retrieved

Secondary Outcome Measures :
  1. pregnancy rate delivery rate maximal serum estradiol levels ovarian reserve measures

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IVF patient
  • Low ovarian response to hormonal stimulation

Exclusion Criteria:

  • Previous DHEA supplementation
  • History of malignant disease
  • Liver dysfunction
  • Coagulation tendency

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): NCT00549081

Contact: Avi Tsafrir, MD +972-2-666211

Sponsors and Collaborators
Shaare Zedek Medical Center
Principal Investigator: Ofer Gonen Meir Hospital, Sapir Medical Center, Kefar-Saba, Israel

Publications: Identifier: NCT00549081     History of Changes
Other Study ID Numbers: DHEA for LR in IVF.CTIL
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: October 25, 2007
Last Verified: October 2007

Keywords provided by Shaare Zedek Medical Center:
low ovarian response

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female