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Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03023774
Collaborator
(none)
20
Enrollment
1
Arm
6
Duration (Months)

Study Details

Study Description

Brief Summary

Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment of thin endometrium or in women with recurrent implantation failure in ICSI cycles

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Prospective analytical study which will be conducted at a private IVF center starting from june 2016.

the study will be recruited from both the fertility clinics and centers by fulfilling inclusion and exclusion criteria , all patient will be subjected to complete history taking medical and fertility history including previous induction or implantation failure.

patients will be randomized into two groups, group A will be treated with neupogen 30 international unit (IU) and group B will be treated with clexane 40mg and estrogen.

study procedure: ovaries were stimulated with standard protocol (long GnRH Agonist) or gonadotrophic releasing hormone (GnRH Antagonist, when at least 3 follicles achieved 18 mm diameter, Human chorionic gonadotrophic (hCG) (10000 IU) was administered for ovulation triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hCG . the oocytes were fertilized by intracytoplasmic sperm injection (ICSI) method. the thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which containing (300 mcg/1 ml) GCSF (neupogen) was infused slowly in the uterine cavity and after 5 days (before embryo transfer) endometrial thickness was evaluated again. all patients received oral and parenteral progesterone for luteal phase support.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Granulocyte Colony-stimulating Factor (GCSF)-Neupogen on Cases With Thin Endometrium or Previous Implantation Failure in ICSI Cycles
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: neupogen

neupogen (granulocyte colony-stimulating factor) 30 IU once intrauterine at the time of ovum pickup

Drug: Neupogen
neupogen 30 IU once intrauterine at the time of ovum pickup
Other Names:
  • granulocyte colony-stimulating factor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. increase in endometrial thickness (above 7 mm) [one week]

    Secondary Outcome Measures

    1. chemical pregnancy (serum beta hCG titre more than (25 mili liter international unit (mIU)/ml) and clinical pregnancy defined as the presence of an intrauterine gestational sac on transvaginal ultrasound (TVS)as 6 weeks. [6 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 36 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • male partner with normal semen analysis according to world health organization (WHO)

    • female partner under the age of 36 presented with: a-thin endometrium (less 7 mm on transvaginal ultrasound) or b- previous history multiple unexplained

    • female with no history of Asherman's syndrome , fibroids, and polyps in diagnostic hysteroscopy

    Exclusion Criteria:
    • women with sickle cell disease, renal insufficiency, upper respiratory infection or pneumonia, chronic neutropenia, known past or present malignancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ain Shams Maternity Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr wessam magdi abuelghar, principal investigator, Ain Shams Maternity Hospital
    ClinicalTrials.gov Identifier:
    NCT03023774
    Other Study ID Numbers:
    • ABT-1233-RV
    First Posted:
    Jan 18, 2017
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Lenograstim

    Study Results

    No Results Posted as of Jan 18, 2017