Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure

Not Applicable

Completed

• Conditions: Fertility Disorders
• Interventions: Drug: Neupogen

• Registration Number: NCT03023774
• Lead Sponsor: Ain Shams Maternity Hospital

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 Timeline

• Study Start: 2016-06
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
increase in endometrial thickness (above 7 mm)	one week

Secondary Outcome Measures

Name	Time	Method
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