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

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132559
• Other study ID #: NSFC30901601
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: May 5, 2014
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Chinese Medical Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• DHEA

Locations

Country	Name	City	State
China	Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rates		12 weeks after gestation.	Yes
Secondary	Clinical pregnancy rate		28 days after the embryo transfer	Yes
Secondary	the number of retrieved oocytes		36-37 hrs after hCG administration	Yes
Secondary	Fertilization rate		on day 1 after oocyte retrieval	Yes
Secondary	Cleavage rate		on day 2 or 3 after oocyte retrieval	Yes
Secondary	Implantation rate		28 days after the embryo transfer	Yes