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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 24, 2007 | ||||
| Last Updated Date | October 24, 2007 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
number of oocytes retrieved | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
pregnancy rate delivery rate maximal serum estradiol levels ovarian reserve measures | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | DHEA Supplementation for Low Ovarian Response IVF Patients | ||||
| Official Title ICMJE | |||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: DHEA | ||||
| Study Arms / Comparison Groups |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 43 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00549081 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | DHEA for LR in IVF.CTIL | ||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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