Granulocyte Stimulating Factor (G-CSF) to Increase the Rate of Implantation Success in IVF Patients in Preferable Preceptive Endometrium Scroe
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- clinical pregnancy per women randomized
研究概览
简要总结
This is a controlled preminary trial intended to increase the implantation rate of IVF cycles, by using more than one known procedure, endometrial scratching, evaluating the status of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1, as a determinant for intervention by G-CSF, according to a score that can be done on a small sample obtained during scratching, then give G-CSF for the scores less than 4 intrauterine and subcutaneously.
详细描述
Placebo: CONTROL patients treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test Drug& scratching CONTROL saline infusion every day from the day of embryo transfer through the day of beta HCG test Other Name: SALINE INFUSION Experimental: G-CSF group patients treated with G-CSF if the biopsy adhesive score 1-3 only
- Endometrial scratching and adhesive factor score, day 21-24 cycle prior to IVF//0rv day 3 of IVF cycle not planned before.
- Drug &scratching : G-CSF group
1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, 2- subcutaneous 300 micrograms G-CSF on the day of embryo transfer Comparative group patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only
Scratching only :
Patients undergoing scratching on day 21-24 of prior IVF cycle/ and on day 5 of IVF cycle with biopsy score of 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
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
- •ALL Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer IN IVF cycle.
排除标准
- •• contraindications for G-CSF treatment (sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia, and congenital fructose intolerance)
研究组 & 干预措施
Placebo
Patients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
干预措施: Saline Solution (Drug)
G-CSF group
Patients treated with G-CSF if the biopsy adhesive score 1-3 only, by Endometrial scratching and adhesive factor scoring on day 21-24 cycle prior to IVF//or day 3 of IVF cycle not planned before.
The dose of G-CSF is 300 µg by trans cervical intrauterine route administered at the oocyte retrieval day, Ans subcutaneous 300µg G-CSF on the day of embryo transfer
干预措施: Endometrial scratch (Procedure)
G-CSF group
Patients treated with G-CSF if the biopsy adhesive score 1-3 only, by Endometrial scratching and adhesive factor scoring on day 21-24 cycle prior to IVF//or day 3 of IVF cycle not planned before.
The dose of G-CSF is 300 µg by trans cervical intrauterine route administered at the oocyte retrieval day, Ans subcutaneous 300µg G-CSF on the day of embryo transfer
干预措施: G-CSF administration (Drug)
Comparative group
patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only
干预措施: Endometrial scratch (Procedure)
结局指标
主要结局
clinical pregnancy per women randomized
时间窗: 4 weeks
pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy
次要结局
- setting a score of precepative endometrium(12 months)
研究者
Areej Khatib
Pathology & clinical labs head department
Istishari Arab Hospital