Vitamin D and Some Antioxidants and Trace Elements Levels in Women: Relationship With I.V.F Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood and follicular fluid vitamin D concentrations
研究概览
简要总结
observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (IVF), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the IVF outcomes until pregnancy occurs or not, based on blood tests. The levels of interested markers in blood and follicular fluid samples of the study individuals are assayed in order to compare these levels with the egg criteria such as egg number and maturation rate and finally compare the results with occurrence or absence of pregnancy.
详细描述
Vitamin D, vitamin E, zinc and glutathione peroxidase will be measured in blood and follicular fluid samples of study subjects for women undergoing in vitro fertilization after monitoring their health for two to three months before beginning the first stage of in vitro fertilization. Once start the ovulation induction protocol, which is the first stage of in vitro fertilization, we will monitor all the results from the number of eggs and follicles, their diameter, the thickness of the endometrium, the number of mature eggs, the egg maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not later, based on the blood Human chorionic gonadotropin (hCG) levels two weeks after the embryos transfer to the uterus. The patient is monitored until clinical pregnancy is complete or not. On the other hand, we will later compare the levels of studied parameters with the aforementioned egg quality criteria and with the clinical pregnancy rate of the study group in order to understand the relationship between these studied parameters and the occurrence of pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Cases of Healthy women (in terms of reproductive function).
- •Aged between 20-40 years and were close in terms of education, nutrition, and social status.
- •Explicit male factor such as Oligospermia, Azoospermia, Asthenozoospermia, or TESA (Testicular Sperm Aspiration), ensuring that there is no fertility-interfering female factor.
- •Undergoing long Gonadotropin-releasing hormone (GnRH) agonist down-regulation protocol.
排除标准
- •Cases classified by the specialist clinician as a female factor such as PCOs (Polycystic Ovary Syndrome), Uterine Fibroids, Uterine Infections, Uterine Adhesions, and Endometriosis.
- •Compound cases.
- •Sex selection cases.
- •Undergoing short GnRH agonist or antagonist protocol.
- •Women aged under 20 or above
- •Women who took nutritional supplements, for at least two to three months before the egg retrieval procedure.
- •Cases with the following medical conditions: Tumors, Diabetes, Multiple sclerosis, Autoimmune Diseases, Liver or Kidney Disorders, Cushing's Syndrome, and women who take chronic medications
研究组 & 干预措施
Pregnant group
A female is considered pregnant when an explicit gestational sac inside the uterus is seen by ultrasound 4 weeks after embryo transfer.
干预措施: human chorionic gonadotropin (Drug)
Non-pregnant group
A female is considered not pregnant when no explicit gestational sac is seen inside the uterus by ultrasound 4 weeks after embryo transfer.
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
Blood and follicular fluid vitamin D concentrations
时间窗: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Blood and follicular fluid vitamin E concentrations
时间窗: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Blood and follicular fluid zinc concentrations
时间窗: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Blood and follicular fluid glutathione peroxidase concentrations
时间窗: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
次要结局
- Biochemical Pregnancy Rate%(2 weeks after embryo transfer)
- Maturation Rate%(Within two hours after oocyte retrieval)
- Embryo Quality(Day of transfer (2 or 3 days after microinjection))
- Number of Metaphase II Oocytes (MII)(Within two hours after oocyte retrieval)
- Fertilization Rate%(16-18 hours after microinjection)
- Clinical Pregnancy Rate% (Per Embryo Transfer)(4 weeks after embryo transfer)
- Number of oocytes retrieved(Immediately after oocyte retrieval)