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Trials. 2019 Jan 15;20(1):50. doi: 10.1186/s13063-018-3146-x.

Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial.

Author information

1
Center for Reproductive Medicine, Key Laboratory of Reproductive Endocrinology, Ministry of Education, and National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Shandong Provincial Clinical medicine Research Center for reproductive health, Shandong Provincial Hospital Affiliated with Shandong University, Shandong University, No. 157 Jing Liu Street, Shizhong district, Jinan, 250012, China.
2
Center for Reproductive Medicine, The Second Clinical Medical College, Yangtze University, No. 2 People Street, Jingzhou district, Jingzhou, 434020, China.
3
Center for Reproductive Medicine, Key Laboratory of Reproductive Endocrinology, Ministry of Education, and National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Shandong Provincial Clinical medicine Research Center for reproductive health, Shandong Provincial Hospital Affiliated with Shandong University, Shandong University, No. 157 Jing Liu Street, Shizhong district, Jinan, 250012, China. shiyuhua2003@126.com.
4
Center for Reproductive Medicine, School of Medicine, Shanghai Key Laboratory for Assisted Reproduction and Reproductive Genetics, Shandong University, Shanghai Jiao Tong University, No. 845 Lingshan Road, Pudong new district, Shanghai, 310101, China.

Abstract

BACKGROUND:

Women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with poor ovarian respond (POR) always have very low clinical pregnancy rates. In previous data, dehydroepiandrosterone (DHEA) was suggested as a promising treatment and maybe has a good pregnancy outcome. But there is no sufficient evidence from randomized clinical trials evaluating the effect of DHEA preconceptional treatment on live birth in POR.

METHODS:

This trial is a multicenter active-placebo double-blind clinical trial (1:1 treatment ratio of active versus placebo). The infertile POR patients undergoing IVF or ICSI will be enrolled and randomly assigned to two parallel groups. Participants in these two groups will be given 4-12 weeks' treatment of DHEA or placebo, respectively. The primary outcome is live birth rate.

DISCUSSION:

The results of this study will provide evidence for the effect of preconceptional DHEA treatment on IVF outcome in POR.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry, ChiCTR-IPR-15006909 . Registered on November 9, 2015.

KEYWORDS:

Dehydroepiandrosterone; In vitro fertilization; Live birth; Poor ovarian response

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