NCT02432248

Effect of DHEA on Patients With Poor Ovarian Responds

Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: The Affiliated Hospital of Inner Mongolia Medical University · Academic / Other
• Sex: Female
• Age: 21 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of DHEA for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.

Detailed description

The aim of this randomized controlled study is to compare the effect of DHEA and placebo on live birth rate in poor ovarian responders. Consecutive infertile women attending the subfertility clinic for IVF treatment will be approached. Those fulfilling the selection criteria would be recruited and a written consent will be obtained after detailed explanation and counseling. Baseline assessment will be performed at early follicular phase (Day 2 or 3) at recruitment. Patient characteristics including age, body mass index (BMI), and smoking status would be recorded and blood test including follicular stimulating hormone (FSH), estradiol (E2), testosterone and anti-Müllerian hormone (AMH) would be checked. Pelvic scan will be performed to assess the total antral follicle count (AFC) and total ovarian volume. Subjects will be randomized divided into two groups: 1. DHEA group: Subjects will take DHEA (Vitacost) 25mg three times a day for 12 weeks prior to the start of IVF treatment. 2. Placebo group: Subjects will take placebo three times a day for 12 weeks prior to the start of IVF treatment. Ultrasound assessment will be repeated in follicular phase (D2 or 3) of every month or cycle followed by a IVF treatment using antagonist protocol based on our standard departmental regimen. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for hormonal profiles.

Conditions

• Subfertility

Interventions

Type	Name	Description
DRUG	Dehydroepiandrosterone	75mg/day, PO for 90 days
OTHER	placebo(medical starch)	75mg/day, PO for 90 days

Timeline

• Start date: 2015-02-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2015-05-04
• Last updated: 2023-07-20

Locations

1 site across 1 country: China