Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Determine the level of Vitamin D in serum and follicular fluid in ng/ml
研究概览
简要总结
Studying the effect of Vitamin D administration on assisted reproductive outcomes in women undergoing Intra Cytoplasmic Sperm Injection (ICSI) by giving a dose of vitamin D and determining the effect of this dose on both the quality embryos, implantation and ongoing pregnancy rate.
详细描述
- Ninty women will include in the study. All patients will be treated with gonadotropin releasing hormone (GnRH) agonist "Decapeptyl" 0.1 mg subcutenoussubcutaneous "FeringFerring, Germany" and vitamin D (D- Dep) from day 20 of the preceding cycle till the day of HCG administration for preparation of ICSI.
- Controlled ovarian hyper stimulation will be done with Gonal F "recombinant FSH", starting from day 3 of the stimulation cycle according to the standard protocol of the center. The dose is calculated according to the ovarian reserve, age as the BMI.
- HCG and Vitamin D will be given when one or more of the growing follicles reaching 17 mm of diameter or more.
- Ovum pickup was done guided by the transvaginal ultrasonography 34-36 hours after HCG administration. Follicular fluid and blood sample were obtained at the time of ovum pickup for ICSI/IVF.
- This prospective randomized case control trial will include 90 women who will be allocated IVF/ICSI. They will be sub divided into a study and a control group; each group will include 45 women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Age is between 20-40 years old.
- •Non PCOS patient.
- •With no previous or current evidence of OHSS (number of oocyte between 5-15 oocytes)
- •Normal Prolactin level.
- •No other endocrinological abnormality including thyroid disorder or diabetes.
- •Within normal ovarian reserve AMH(1-3) ng/ml No evidence of endometriosis.
- •No other medical or surgical diseases.
- •10-Careful history, general and local examination, abdominal and vaginal ultrasonography and basal haematological and chemical investigations were done
- •to exclude any other abnormalities which can interfere with the result of the current study.
排除标准
- •Women older than 35 years of age or younger than 20 years old
- •Women with polycystic ovary syndrome PCOS (as defined according to the Rotterdam criteria)
- •Women who were diagnosed to have endometriosis within the last 1 year.
- •Women with ovarian hyper stimulation syndrome (OHSS).
- •Sever male factor infertility with immotile sperm which may affect embryo development
- •poor responder patient .
研究组 & 干预措施
control
Control group in which vitamin D was not administrated.
干预措施: Vitamin D (Drug)
Study group
Study group in which Vitamin D was administered
干预措施: Vitamin D (Drug)
结局指标
主要结局
Determine the level of Vitamin D in serum and follicular fluid in ng/ml
时间窗: Stimulated Cycle a bout one month
Determine the level of Vitamin D in serum and follicular fluid in stimulated cycle for IVF/ICSI in normal responder women and comparison its level between study group (in which Vitamin D was administered) and control group ( in which vitamin D was not administrated) and its effect on oocyte quality by the use of ELISA test
Determine the level of BMP-15 in follicular fluid
时间窗: Stimulated Cycle within one month
2- Determine the level of BMP-15 in follicular fluid in stimulated cycle for IVF/ICSI in normal responder women and comparison its level between study group(in which Vitamin D was administered) and control group ( in which vitamin D was not administrated) and its effect on oocyte quality by Western Plot test
次要结局
- To find if there is a correlation between serum and follicular fluid level of Vitamin D in the same patient.(Stimulated Cycle within one month)
- 4- To find if there is a relation between vitamin D and BMP 15 levels and other hormones like AMH, FSH, E2, TSH and prolactin(Stimulated Cycle within one month)
研究者
Radwa Adel Hanafy
Principle investigator
Assiut University