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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02132559
Enrollment
386
Registered
2014-05-07
Start date
2011-10-31
Completion date
2013-07-31
Last updated
2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

DRUGDHEA

Sponsors

Chinese Medical Association
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
23 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
ongoing pregnancy rates12 weeks after gestation.

Secondary

MeasureTime frame
Clinical pregnancy rate28 days after the embryo transfer
the number of retrieved oocytes36-37 hrs after hCG administration
Fertilization rateon day 1 after oocyte retrieval
Cleavage rateon day 2 or 3 after oocyte retrieval
Implantation rate28 days after the embryo transfer

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026