Growth Hormone and Dehydroepiandrosterone Effect on Poor Ovarian Reserve Patients During in Vitro Fertilization
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- The number of mature oocyte
研究概览
简要总结
The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder.
The main question it aims to answer is:
Which intervention is more effective in increasing number and size of follicles? Participants will be followed 1 month before starting induction in growth hormone and 12 weeks for DHEA and through intracytoplasmic sperm injection (ICSI) cycle.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least two of the following three criteria had to be present after maximal stimulation:
- •Advanced maternal age (>40 years) or any other risk factor for Poor Ovarian Response (POR).
- •≤3 oocytes with a conventional stimulation protocol).
- •An abnormal ovarian reserve test [i.e. antral follicle count (AFC) less than 5-7 follicles or anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml].
排除标准
- •Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction.
- •Any pelvic pathology such as hydrosalpinx, uterine anomaly.
- •Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia
研究组 & 干预措施
Standard care
Patients will receive standard care will receive folic acid 400 mcg per day
干预措施: control group (Dietary Supplement)
Somatropin group
Somatropin (4IU for 1 month) 1 S.C injection every 3 days for at least 1 month plus, folic acid 400mcg/day
干预措施: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day. (Drug)
dehydroepiandrosterone
dehydroepiandrosterone 50 mg twice per day for 12 weeks plus folic acid 400mcg per day
干预措施: DHEA plus folic acid 400mcg per day (Drug)
结局指标
主要结局
The number of mature oocyte
时间窗: 12 weeks
次要结局
- pregnancy rate(12 weeks)
研究者
Hasnaa Osama
Lecturer of Clinical Pharmacy, Beni-Suef University
Beni-Suef University