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Trial record 34 of 237 for:    PRASTERONE

Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02132559
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):
Chinese Medical Association

Brief Summary:

Women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen for poor responders is currently unknown.

Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor responders, and is now utilized by approximately one third of all IVF centers world-wide. However, the current clinical evidence for DHEA on improvement of ovarian response and IVF outcome is insufficient. The validity of the results of the former studies, especially the varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been performed study to evaluate the potential effects of DHEA supplementation according to these standards.

The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of poor ovarian responders that fulfill the Bologna criteria.

Condition or disease Intervention/treatment
Infertility Drug: DHEA

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Study Type : Observational
Actual Enrollment : 386 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Group/Cohort Intervention/treatment
DHEA administration,no treatment
The patients of study group received DHEA 25 mg orally,three times a day before the IVF cycle. Except for IVF, the control group of patients did not receive any pre-treatment.
Drug: DHEA
Other Name: dehydroepiandrosterone

Primary Outcome Measures :
  1. ongoing pregnancy rates [ Time Frame: 12 weeks after gestation. ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 28 days after the embryo transfer ]
  2. the number of retrieved oocytes [ Time Frame: 36-37 hrs after hCG administration ]
  3. Fertilization rate [ Time Frame: on day 1 after oocyte retrieval ]
  4. Cleavage rate [ Time Frame: on day 2 or 3 after oocyte retrieval ]
  5. Implantation rate [ Time Frame: 28 days after the embryo transfer ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients were stratified according to the Bologna criteria for poor ovarian response. Poor responders were classified with at least two of the three following criteria: (I) advanced maternal age (≥40 years) or any other risk factor for POR; (II) a previous POR(≤3 oocytes with a conventional ovarian stimulation protocol); and (III) an abnormal ovarian reserve test (ORT): antral follicle count (AFC) < 5-7 or serum anti-Mullerian hormone (AMH) <0.5-1.1 ng/mL, as described by the Bologna criteria

Inclusion Criteria:

Patients with poor ovarian response according to the Bologna criteria

Exclusion Criteria:

women aged > 45 years or baseline follicle stimulating hormone(FSH)levels >40 IU/l.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02132559

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China, Hubei
Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Chinese Medical Association
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Study Director: Guijin Zhu Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology

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Responsible Party: Chinese Medical Association Identifier: NCT02132559    
Other Study ID Numbers: NSFC30901601
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: July 2013
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs