Effects of Granulocyte Colony-stimulating Factor (GCSF)-Neupogen on Cases With Thin Endometrium or Previous Implantation Failure in ICSI Cycles
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 20
- Primary Endpoint
- increase in endometrial thickness (above 7 mm)
Study Overview
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
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 36 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
neupogen
neupogen (granulocyte colony-stimulating factor) 30 IU once intrauterine at the time of ovum pickup
Intervention: Neupogen (Drug)
Outcomes
Primary Outcomes
increase in endometrial thickness (above 7 mm)
Time Frame: one week
Secondary Outcomes
- 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)
Investigators
Dr wessam magdi abuelghar
principal investigator
Ain Shams Maternity Hospital