The Effect of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve Parameters and Intra-cytoplasmic Sperm Injection Outcomes in Patient With Poor Ovarian Reserve: an Open Label Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pregnancy
研究概览
简要总结
To evaluate the role of Myo-inositol, melatonin and co-enzyme Q10 on ovarian reserve parameters and ICSI outcome in poor ovarian responder
详细描述
Each patient will be subjected to:
Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on day 2 to day 3 of menstruation. Routine labs as CBC, liver & kidney functions to exclude general disease as a contraindication for induction or pregnancy.
Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) from day 2-3 of menstruation, with daily dose of 300-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. . For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day. The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women who have one of the criteria of poor ovarian response as follows;
- •Antral follicle count less than 7
- •Anti-Mullerian hormone level Less than 1.2 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
myo-inositol
myo-inositol (1gm capsules bd ) plus folic acid 400 mcg per day
干预措施: Myoinositol (Drug)
melatonin
melatonin 1 capsule every night orally before going to bed plus folic acid 400mcg per day
干预措施: Melatonin (Drug)
co-enzyme Q10
co-enzyme Q10 100mg per day plus folic acid 400 mcg per day
干预措施: Co-Enzyme Q10 (Drug)
control group.
will receive folic acid 400 mcg per day
干预措施: Folic acid (Drug)
结局指标
主要结局
pregnancy
时间窗: 1 month of induction for ICSI trial
serum HCG positive
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University
