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

Primary Purpose

Women Infertility

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Endometrial scratch
G-CSF administration
Saline Solution
Sponsored by
Istishari Arab Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Women Infertility focused on measuring IVF

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Sham Comparator

    Arm Label

    Placebo

    G-CSF group

    Comparative group

    Arm Description

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

    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

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

    Outcomes

    Primary Outcome Measures

    clinical pregnancy per women randomized
    pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy

    Secondary Outcome Measures

    setting a score of precepative endometrium
    Evaluation of the endometrial biopsy and setting a receptive score/ adhesive factors of the endometrium

    Full Information

    First Posted
    May 21, 2017
    Last Updated
    June 16, 2017
    Sponsor
    Istishari Arab Hospital
    Collaborators
    Salem Abu Khyzaran, Nizam Najeeb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03163862
    Brief Title
    G-CSF Administration in IVF in a Preferable Preceptive Endometrium Score
    Official Title
    Granulocyte Stimulating Factor (G-CSF) to Increase the Rate of Implantation Success in IVF Patients in Preferable Preceptive Endometrium Scroe
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2017 (Anticipated)
    Primary Completion Date
    June 1, 2018 (Anticipated)
    Study Completion Date
    January 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istishari Arab Hospital
    Collaborators
    Salem Abu Khyzaran, Nizam Najeeb

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 Endometrial scratching and adhesive factor score, day 21-24 cycle prior to IVF//0rv day 3 of IVF cycle not planned before. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Women Infertility
    Keywords
    IVF

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
    Arm Title
    G-CSF group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Comparative group
    Arm Type
    Sham Comparator
    Arm Description
    patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only
    Intervention Type
    Procedure
    Intervention Name(s)
    Endometrial scratch
    Intervention Description
    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
    Drug
    Intervention Name(s)
    G-CSF administration
    Intervention Description
    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
    Intervention Name(s)
    Saline Solution
    Intervention Description
    saline infusion every day from the day of embryo transfer through the day of beta HCG test
    Primary Outcome Measure Information:
    Title
    clinical pregnancy per women randomized
    Description
    pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    setting a score of precepative endometrium
    Description
    Evaluation of the endometrial biopsy and setting a receptive score/ adhesive factors of the endometrium
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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