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DHEA Supplementation for Low Ovarian Response IVF Patients
This study is not yet open for participant recruitment.
Verified by Shaare Zedek Medical Center, October 2007
Sponsored by: Shaare Zedek Medical Center
Information provided by: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00549081
  Purpose

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 Intervention
Infertility, Female
In-Vitro Fertilization
Dietary Supplement: DHEA

MedlinePlus related topics: Dietary Supplements Infertility
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • number of oocytes retrieved

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

Study Start Date: January 2008
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
1: Experimental
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
2: No Intervention
IVF patient who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IVF patient
  • Low ovarian response to hormonal stimulation

Exclusion Criteria:

  • Previous DHEA supplementation
  • History of malignant disease
  • Liver dysfunction
  • Coagulation tendency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549081

Contacts
Contact: Avi Tsafrir, MD +972-2-666211 avits@scmz.org.il

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

Publications:
Study ID Numbers: DHEA for LR in IVF.CTIL
Study First Received: October 24, 2007
Last Updated: October 24, 2007
ClinicalTrials.gov Identifier: NCT00549081  
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
DHEA
IVF
low ovarian response

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Infertility, Female
Dehydroepiandrosterone
Genital Diseases, Male

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009