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| Name | Class |
|---|---|
| Salem Abu Khyzaran | UNKNOWN |
| Nizam Najeeb | UNKNOWN |
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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.
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- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test |
|
| G-CSF group | Experimental | 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 | Sham Comparator | patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial scratch | Procedure | the intervention group, endometrial biopsy will be performed with a pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France). The pipelle was introduced gently through the cervix up to the uterine fundus. the examiner applied regular back-and-forth movements (2-4 cm) during a period of 30 s. The obtained specimens will be sent for histology evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy per women randomized | pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| setting a score of precepative endometrium | Evaluation of the endometrial biopsy and setting a receptive score/ adhesive factors of the endometrium | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| G-CSF administration | Drug | 1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, subcutaneous 300 micrograms G-CSF on the day of embryo transfer |
|
| Saline Solution | Drug | saline infusion every day from the day of embryo transfer through the day of beta HCG test |
|