The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number and maturity of oocytes retrieved
研究概览
简要总结
To evaulate the role of Myo-inositol, somatropin, DHEA on 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 D2 to 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 150-300 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.
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
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1-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 2- females with body mass index (BMI) from 19-25
排除标准
- •Any endocrine or metabolic disorder such as polycystic ovary syndrome,
- •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
will recive Inofolic (myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks
干预措施: myo-inositol (Drug)
Somatropin
Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.
干预措施: Somatropin (Drug)
Dehydroepiandrosterone
DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.
干预措施: Dehydroepiandrosterone (Drug)
结局指标
主要结局
Number and maturity of oocytes retrieved
时间窗: 1 month
Number and maturity of oocytes retrieved (M1/M2)
次要结局
- chemical pregnancy rate(1 month)
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University