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Completed

NCT Number: NCT02132559

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

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.

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Key information

Age range

23 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DHEA

Drug

Other names: dehydroepiandrosterone

Primary outcomes

  1. ongoing pregnancy rates

    Time frame: 12 weeks after gestation.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 7, 2014
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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