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

Women Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03163862
• Other study ID #: 0001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: May 21, 2017
• Last updated: June 16, 2017
• Start date: August 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: June 2017
• Source: Istishari Arab Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Women Infertility

Intervention

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
• Saline Solution
saline infusion every day from the day of embryo transfer through the day of beta HCG test

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Istishari Arab Hospital	Nizam Najeeb, Salem Abu Khyzaran

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy per women randomized	pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy	4 weeks
Secondary	setting a score of precepative endometrium	Evaluation of the endometrial biopsy and setting a receptive score/ adhesive factors of the endometrium	12 months