Variation in Serum Prolactin Levels in Response to Ovum Pickup for Patients Undergoing ICSI & it's Effect on Pregnancy Rate
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer
研究概览
简要总结
The purpose of the study is to determine whether or not stressful conditions such as ovum pick and awaiting Embryo Transfer is associated with significant increase in serum Prolactin (PRL) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm injection (ICSI) & possible effect on implantation & pregnancy rate.
详细描述
Methodology in details:
After applying inclusion and exclusion criteria to infertile patients scheduled for start of ICSI cycle at kasr alainy assisted reproduction unit, and taking the patient's informed consent for all blood samples that will be drawn from her.
The baseline serum prolactin level is recorded and the first blood sample is scheduled to be taken in operating room just before induction of anesthesia for ovum pickup. A Second blood sample will be taken two hours after aspiration of the last follicle in recovery room post-operatively.
A third final blood sample will be taken before Embryo transfer .The blood samples will be sent immediately to central laboratory in Kasr Alainy Cairo University Hospital after being obtained on every occasion, and Serum prolactin will be analyzed by immunoassay in each time.
Descriptive data such as age, type of infertility & cause will be recorded. Also result of every serum prolactin level will be recorded as well as type of protocol used for ovulation induction, number of oocytes retrieved at ovum pick up, embryo grading and day of transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: adult female >20 years old.
- •Complaining of infertility 1ry or 2ry & scheduled for ICSI.
排除标准
- •Hyperprolactinemia patients.
- •Severe Male factor infertility
- •Frozen embryo transfer cycles
- •Uterine Anomalies.
- •Repeated implantation failure in ICSI.
- •Any contraindications for Pregnancy as(serious uncontrolled medical diseases such as Diabetes, heart disease, hypertension), mental illnesses, ovarian tumors,cancer of any location and Acute inflammatory disease).
- •On medication that is known to alter prolactin levels e.g antipsychotics, Atypical agents and risperidone
- •Thyroid dysfunction.
- •Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and hypothyroidism.
结局指标
主要结局
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer
时间窗: 6 months
次要结局
- o Correlate serum prolactin levels (ng/mL) with Pregnancy rate.(6 months)
- Correlate serum prolactin levels (ng/mL) with number & quality of embryos(6 months)
研究者
Ahmed M.Kamel
Lecturer of Obstetric & Gynecology
Kasr El Aini Hospital