NCT03163862

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

Granulocyte Stimulating Factor (G-CSF) to Increase the Rate of Implantation Success in IVF Patients in Preferable Preceptive Endometrium Scroe

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Istishari Arab Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Women Infertility

Interventions

Type	Name	Description
PROCEDURE	Endometrial scratch	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.
DRUG	G-CSF administration	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
DRUG	Saline Solution	saline infusion every day from the day of embryo transfer through the day of beta HCG test

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-06-01
• Completion: 2019-01-01
• First posted: 2017-05-23
• Last updated: 2017-06-19