Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure

NCT ID: NCT03023774

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Fertility Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neupogen

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

Group Type: OTHER

Neupogen

Intervention Type: DRUG

neupogen 30 IU once intrauterine at the time of ovum pickup

Interventions

Neupogen

neupogen 30 IU once intrauterine at the time of ovum pickup

Intervention Type: DRUG

Other Intervention Names

granulocyte colony-stimulating factor

Eligibility Criteria

Inclusion Criteria

• male partner with normal semen analysis according to world health organization (WHO) 2010.
• 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

• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr wessam magdi abuelghar

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ABT-1233-RV

Identifier Type: -

Identifier Source: org_study_id