Study the Effects of Intrauterine Flushing With Low Dose Human Chorionic Gonadotropin on Ultrasound Parameter and Immunological Marker of Endometrial Receptivity of Infertile Female Undergoing ICSI Cycle
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer
研究概览
简要总结
a number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter.
详细描述
Ninety infertile women included. Written informed consent was obtained before being included in the study. Three groups of patients according to type of intervention. Assessment of plasma hormone level was done for all. The quantification of serum TNF and IL-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (ELISA) methodology at a privately-owned laboratory.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient's consent to participate in the research study is crucial for data collection and analysis.
- •Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process.
- •The age range of the female participants varied from 18 to 40 years.
- •Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined.
- •Male-related factors contributing to infertility were also taken into consideration.
- •The procedure involved the transfer of grade one embryos during a fresh cycle.
排除标准
- •Endometrioses, whether clinically suspected or discovered during laparoscopy, are of interest.
- •2. Instances of congenital abnormalities in the reproductive system are being examined.
- •3. Individuals above the age of forty are under consideration.
- •Individuals who do not possess G1 embryos are also included.
- •Patients with chronic systemic conditions (such as diabetes, hematologic disorders, hypertension, autoimmune disorders of the connective tissue, asthma, thyroid disorders) are a part of the study.
- •6. The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.
研究组 & 干预措施
Group B
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
干预措施: hCG (Drug)
Group A
Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
干预措施: hCG (Drug)
结局指标
主要结局
Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer
时间窗: at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent
All participants in the study had a blood sample taken on the day of ovum retrieval (within 10 minute after ova pickup) for the purpose of measuring the level of interleukin-10 and TNF-alfa in the blood, and a second sample was taken on the day of embryo transfer (ten minute before embryo transfer) to asses both marker,
Ultrasound Parameter (RI,PI)
时间窗: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device
assessment of sub-endometrial blood flow indicis immediately within 10 minute post ova pickup and second exam within ten minute before embryo transfer day which is within 3-5 days of ova pickup there are no maximum or minimum value for the parameter to be measured and lower value is better these measure was performed by using ultrasound device
Systole Flow/ Diastole Flow
时间窗: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio
TNF-alfa/IL-10 Ratio
时间窗: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
ratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer
次要结局
- Intra Cytoplasmic Sperm Injection Outcome(14 days after embryo transfer beta-hCG titer performed to asses pregnancy)
研究者
Omayma Ismail Khalaf
principal investigator
Al-Nahrain University