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DHEA Supplementation for Low Ovarian Response IVF Patients

Primary Purpose

Infertility, Female, In-Vitro Fertilization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DHEA
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring DHEA, IVF, low ovarian response

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • IVF patient
  • Low ovarian response to hormonal stimulation

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    IVF patients who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.

    IVF patient who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.

    Outcomes

    Primary Outcome Measures

    number of oocytes retrieved

    Secondary Outcome Measures

    pregnancy rate delivery rate maximal serum estradiol levels ovarian reserve measures

    Full Information

    First Posted
    October 24, 2007
    Last Updated
    October 24, 2007
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00549081
    Brief Title
    DHEA Supplementation for Low Ovarian Response IVF Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2008 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female, In-Vitro Fertilization
    Keywords
    DHEA, IVF, low ovarian response

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    IVF patients who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    IVF patient who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    DHEA
    Intervention Description
    oral DHEA tablets 75 mg daily
    Primary Outcome Measure Information:
    Title
    number of oocytes retrieved
    Secondary Outcome Measure Information:
    Title
    pregnancy rate delivery rate maximal serum estradiol levels ovarian reserve measures

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    43 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: IVF patient Low ovarian response to hormonal stimulation Exclusion Criteria: Previous DHEA supplementation History of malignant disease Liver dysfunction Coagulation tendency
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Avi Tsafrir, MD
    Phone
    +972-2-666211
    Email
    avits@scmz.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ofer Gonen
    Organizational Affiliation
    Meir Hospital, Sapir Medical Center, Kefar-Saba, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16997936
    Citation
    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. doi: 10.1093/humrep/del254. Epub 2006 Sep 22.
    Results Reference
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    DHEA Supplementation for Low Ovarian Response IVF Patients

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