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

May 5, 2014 updated by: Chinese Medical Association

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 Names:
  • dehydroepiandrosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ongoing pregnancy rates
Time Frame: 12 weeks after gestation.
12 weeks after gestation.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Medical Association

Investigators

  • Study Director: Guijin Zhu, Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC30901601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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