DHEA Supplementation for Low Ovarian Response IVF Patients

Study Overview
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Brief Summary
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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.

Conditions
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Infertility, Female, In-Vitro Fertilization

Intervention / Treatment
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* Dietary Supplement: DHEA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IVF patient Low ovarian response to hormonal stimulation Exclusion Criteria: Previous DHEA supplementation History of malignant disease Liver dysfunction Coagulation tendency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IVF patients who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH. | Dietary Supplement: DHEA<br>* oral DHEA tablets 75 mg daily<br>|
| No Intervention: 2<br>IVF patient who had a low ovarian response in a previous hormonal-stimulation treatment, treated with recombinant FSH and LH. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate delivery rate maximal serum estradiol levels ovarian reserve measures |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHEA, IVF, low ovarian response