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

Completed

• Conditions: Infertility
• Interventions: Drug: DHEA

• Registration Number: NCT02132559
• Lead Sponsor: Chinese Medical Association

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Last Update Submitted: 2014-05-05
• Study First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 386

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DHEA administration,no treatment	DHEA	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.

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rates	12 weeks after gestation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China