G-CSF Administration in IVF in a Preferable Preceptive Endometrium Score

Istishari Arab Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Women Infertility

Treatments: Procedure: Endometrial scratch; Drug: G-CSF administration; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03163862

0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ALL Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer IN IVF cycle.

Exclusion criteria

• • 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test

Treatment:

Drug: Saline Solution

G-CSF group

Experimental group

Description:

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

Treatment:

Procedure: Endometrial scratch

Drug: G-CSF administration

Comparative group

Sham Comparator group

Description:

patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only

Treatment:

Procedure: Endometrial scratch