A Randomized Controlled Trial on the Effect of Dehydroepiandrosterone (DHEA) Supplementation on Ovarian Reserve Markers, Response to a Standard Low Dose FSH Stimulation and IVF Cycle Outcomes in Patients With Normal and Poor Ovarian Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Antral follicle count
研究概览
简要总结
The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve markers, ovarian response to gonadotrophins and cycle outcomes in patients with normal and poor ovarian reserve.
Study Hypotheses:
- DHEA supplementation would improve markers of ovarian reserve and ovarian response to low dose FSH stimulation in both normal and poor responders
- DHEA supplementation would improve IVF cycle outcomes
详细描述
Consecutive patients attending subfertility clinic at the Department of Obstetrics and Gynaecology, Queen Mary Hospital who are scheduled for in-vitro fertilization (IVF) treatment will be recruited and written consent will be obtained.
Baseline assessment will be performed at early follicular phase (Day 2 or 3) with hormonal tests and ultrasound.
Subjects will be divided into two groups, the normal ovarian reserve group and the poor ovarian reserve group according to AFC. Poor ovarian reserve is defined as an AFC of less than 5, while normal ovarian reserve is defined as an AFC of 5 to 15 based on a previous study showing AFC being a good predictor of ovarian response (Tomas 1997). Subjects with normal ovarian reserve will be further subdivided into <35 and >/=35 years old while subjects with poor ovarian reserve will be further subdivided into first or subsequent cycles of IVF for subgroup analysis.
Subjects in both the normal and poor ovarian reserve group will be randomized according to a computer-generated randomization list in sealed envelopes to receive either DHEA at 25mg three times a day or placebo throughout the study period.
Any changes in hormonal profile and ovarian reserve will be assessed by the above-mentioned blood tests and pelvic ultrasound scans which will be repeated at early follicle phase (Day 2 or 3) in the two subsequent cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indicated for IVF treatment according to our standard department protocol
- •Age < 40
- •Regular menstrual cycles (21-35 days with </= 4 days inter-cycle variation)
- •AFC not more than 15
排除标准
- •Previous chemotherapy or pelvic irradiation
- •Polycystic ovarian syndrome or polycystic ovaries
- •On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
研究组 & 干预措施
Dihydroepiandrosterone (DHEA)
DHEA 25mg 3 times a day for 12 weeks
干预措施: Dihydroepiandrosterone (DHEA) (Dietary Supplement)
Placebo
Matched placebo capsules are given 3 times a day for 12 weeks
结局指标
主要结局
Antral follicle count
时间窗: after 12 weeks of DHEA
Compare the changes in antral follicle count after 12 weeks of DHEA supplementation prior to IVF treatment between the treatment and placebo groups
次要结局
- Change in Follicular stimulating hormone (FSH) and anti-Mullerian Hormone (AMH) following DHEA supplementation; post stimulation estradiol level and number of follicles > 10mm, IVF outcomes, hormonal profile of follicular fluid(after 12 weeks of DHEA)
研究者
Yeung Wing Yee Tracy
Associate Consultant
The University of Hong Kong