The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation on the Number of Oocytes Obtained During IVF in Poor Ovarian Responders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Number of Oocytes Obtained
研究概览
简要总结
The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for patients with previous poor ovarian reserve and response in an attempt to improve pregnancy outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the use,especially in Asian people. Whether the double dosage of DHEA in patients with poor ovarian reserve and response in China can improve the IVF outcome with little side effect is unknown.
The aim of this randomized controlled study is to compare the effect of a higher dose (150mg daily) and a standard dose (75mg daily) of DHEA on the number of oocytes obtained in poor ovarian responders. The effect of DHEA action on the cumulus cells will be examined.
详细描述
Consecutive infertile women attending the subfertility clinic at Shang Hai Ji Ai Genetics &IVF Institute for IVF treatment will be approached. Those fulfilling the selection criteria stated below would be recruited and a written consent will be obtained after detailed explanation and counseling.
Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:
(i) Advanced maternal age (>/= 40) or any other genetic or acquired risk factor for poor ovarian response(POR); (ii) Previous poor ovarian response (POR) (</= 3 oocytes with a conventional stimulation protocol using at least 150 international units (IU) gonadotrophins per day) (iii) Abnormal ovarian reserve test [i.e. antral follicle count (AFC) < 5-7 or antimüllerian hormone (AMH) < 0.5 - 1.1ng/ml]
Alternatively, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test(ORT).
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, DHEA-S, full blood count, renal and liver function test would be checked. Pelvic scan will be performed to assess the total AFC and total ovarian volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age<45 years,
- •subfertility >1 year, and
- •A previous POR (≤3 oocytes with a conventional stimulation protocol of at least 150 IU FSH per day); or
- •An abnormal ovarian reserve test (i.e. AFC ≤5-7 follicles or AMH ≤0.5-1.1 ng/ml).
排除标准
- •Patients were excluded if they:
- •had a history of ovarian cystectomy or oophorectomy,
- •had received cytotoxic chemotherapy,
- •had received pelvic irradiation, or
- •had a history of taking testosterone or DHEA supplementation
结局指标
主要结局
The Number of Oocytes Obtained
时间窗: After taking DHEA for 12 weeks
After 12 weeks treatment, the number of oocytes obtained will be detected from the higher dose group and standard dose group
次要结局
- AFC(After taking DHEA for 12 weeks)
- Follicle Stimulating Hormone (FSH) Levels(12 weeks after taking DHEA)
- E2(12 weeks after taking DHEA)
- The Number of Follicles>10mm(12 weeks after taking DHEA)
- AMH(baseline and 12 weeks)
- Testosterone(12 weeks after taking DHEA)
- Dehydroepiandrosterone-Sulfide (DHEA-S)(12 weeks after taking DHEA)
- Insulin-like Growth Factor-1 (IGF-1)(12 weeks after taking DHEA)