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

NCT ID: NCT03163862

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

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

G-CSF group

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

Group Type: EXPERIMENTAL

Endometrial scratch

Intervention Type: 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.

G-CSF administration

Intervention Type: 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

Comparative group

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

Group Type: SHAM_COMPARATOR

Endometrial scratch

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Saline Solution

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Salem Abu Khyzaran

UNKNOWN

Sponsor Role: collaborator

Nizam Najeeb

UNKNOWN

Sponsor Role: collaborator

Istishari Arab Hospital

OTHER

Sponsor Role: lead

Responsible Party

Areej Khatib

Pathology & clinical labs head department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id