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

NCT ID: NCT02132559

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 386 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-07-31

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

DHEA

Intervention Type: DRUG

Interventions

DHEA

Intervention Type: DRUG

Other Intervention Names

dehydroepiandrosterone

Eligibility 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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guijin Zhu

Role: STUDY_DIRECTOR

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

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

NSFC30901601

Identifier Type: -

Identifier Source: org_study_id