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DHEA Supplementation for Low Ovarian Response IVF Patients

NCT ID: NCT00549081

Last Updated: 2007-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

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.

Detailed Description

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Conditions

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Infertility, Female In-Vitro Fertilization

Keywords

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DHEA IVF low ovarian response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

DHEA

Intervention Type DIETARY_SUPPLEMENT

oral DHEA tablets 75 mg daily

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DHEA

oral DHEA tablets 75 mg daily

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Ofer Gonen

Role: PRINCIPAL_INVESTIGATOR

Meir Hospital, Sapir Medical Center, Kefar-Saba, Israel

Central Contacts

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Avi Tsafrir, MD

Role: CONTACT

Phone: +972-2-666211

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 16997936 (View on PubMed)

Other Identifiers

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DHEA for LR in IVF.CTIL

Identifier Type: -

Identifier Source: org_study_id