Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Implantation rates
研究概览
简要总结
One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.
详细描述
This study is a randomized clinical trial to investigate implantation rate and clinical pregnancy after intrauterine flushing of infertile patients with follicular fluid plus granulosa cells - Randomized controlled trials. The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute and all participants provide informed consent.
The main objective of this study is evaluation of implantation rate and clinical pregnancy after flushing of uterine in infertile patients with follicular fluid plus granulosa cells in IVF/ ICSI cycles.
Material and methods
In a randomized clinical trial, 140 patients with Male factor infertility referring to infertility clinic of Royan Institute, Iran, who received ovarian stimulation with antagonist and agonist protocol, will be randomly assigned to two groups: in case group, if the follicular fluid of two clear dominant follicles contain at least 2 COC, after removal of the COCs, follicular fluid will be collected Endometrial cavity flushing with 2 ml of follicular fluid will be performed by IUI caterer. In control group only catheterization of uterine cavity will be performed. Primary outcome is comparison of implantation rate between case and control group. Secondly outcome is assessment of clinical pregnancy rate in both groups.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal Hormonal profile (FSH, LH, AMH) and normal AFC
- •Normal ovarian reserve
- •Age 20-38 years
- •Regular menstrual cycle
- •IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol
- •Existence of at least 2 oocytes in dominant follicular fluids
排除标准
- •Presence of Endometriosis and Endometrioma
- •Hydrosalpinx
- •OHSS (Ovarian Hyper Stimulating Syndrome)
- •Tubal factor infertility
- •Male factor infertility with azoospermia
- •Low/Poor Response
- •Myoma with a compression effect or submocusa myometrium
- •Intra mural or subserouse Myoma > 5cm
- •Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection.
- •Endometrial tuberculosis
- •The follicular fluid which contains any oocyte or contaminated with blood will be discarded
结局指标
主要结局
Implantation rates
时间窗: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred
次要结局
- Clinical pregnancy rate(4-6 weeks after embryo transfer)