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
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring DHEA, IVF, low ovarian response
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
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
NCT ID
NCT00549081
First Posted
October 24, 2007
Last Updated
October 24, 2007
Sponsor
Shaare Zedek Medical Center
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
background
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DHEA Supplementation for Low Ovarian Response IVF Patients
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