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

NCT03163862 | Unknown Phase 2

• 1 other identifier: 0001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Women Infertility

Keywords

IVF

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy per women randomized

  pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy

  4 weeks

Secondary Outcomes (1)

• setting a score of precepative endometrium

  12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Saline Solution

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

Procedure: Endometrial scratch; Drug: G-CSF administration

Comparative group

SHAM COMPARATOR

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

Procedure: Endometrial scratch

Interventions

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.

Comparative group; G-CSF group

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

G-CSF group

Saline Solution DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Women aged \< 40 years who would be submitted to oocyte retrieval and embryo transfer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istishari Arab Hospital: lead
• Salem Abu Khyzaran: collaborator
• Nizam Najeeb: collaborator

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pathology & clinical labs head department

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 23, 2017
• Study Start: August 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 19, 2017

Record last verified: 2017-06