Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
- To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment.
- To evaluate the feasibility of conducting a large multicentre trial
详细描述
The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers.
This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count <10 and/or Anti-Mullerian hormone <5pmol/L
- •Women undergoing IVF and IVF/ICSI treatment
- •Women must have a regular spontaneous menstrual cycle of 21 - 35 days
排除标准
- •Women with BMI >35 Kg/M2
- •Women with a single ovary
- •Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment
- •Women with any history of seizure disorders
- •Women with previous participation in this trial in an earlier treatment cycle
- •Women with any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia
- •Known allergy to DHEA
- •Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements.
研究组 & 干预措施
DHEA supplementation
干预措施: Dehydroepiandrosterone (Drug)
Control
干预措施: Placebo (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: within 15 weeks after DHEA/Placebo supplementation
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
Feasibility to conduct a large multicentre randomised controlled trial
时间窗: with in 20 weeks of the research period (per participant)
Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates
次要结局
- Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology(The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.)
- Oocyte quality (clinical and molecular markers)(The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.)