G-CSF Administration in IVF in a Preferable Preceptive Endometrium Score
- Conditions
- Women Infertility
- Interventions
- Registration Number
- NCT03163862
- Lead Sponsor
- Istishari Arab Hospital
- Brief Summary
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.
- Detailed Description
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
1. Endometrial scratching and adhesive factor score, day 21-24 cycle prior to IVF//0rv day 3 of IVF cycle not planned before.
2. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- ALL Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer IN IVF cycle.
- • 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Saline Solution Patients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test G-CSF group Endometrial scratch 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 Comparative group Endometrial scratch patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only G-CSF group G-CSF administration 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
- Primary Outcome Measures
Name Time Method clinical pregnancy per women randomized 4 weeks pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy
- Secondary Outcome Measures
Name Time Method setting a score of precepative endometrium 12 months Evaluation of the endometrial biopsy and setting a receptive score/ adhesive factors of the endometrium