Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure

Ain Shams Maternity Hospital

Status: Completed

Conditions: Fertility Disorders

Treatments: Drug: Neupogen

Study type: Interventional

Funder types: Other

Identifiers

NCT03023774

ABT-1233-RV

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: Under 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

neupogen

Other group

Description:

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

Treatment:

Drug: Neupogen