A Randomized Clinical Trial Oof Intrauterine GCS in Unexplained Repeated Implantation Failure (RIF) Patients: May Intrauterine GCSF Improve Clinical & Ongoing Pregnancy Rate or Decrease Abortion

سال انتشار: 1397
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 481

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شناسه ملی سند علمی:

ISERB04_046

تاریخ نمایه سازی: 16 تیر 1397

چکیده مقاله:

Background: To study whether intrauterine granulocyte colony stimulating factor (GCSF) improves the rates of clinical and ongoing pregnancy or decreases abortion rate inunexplained repeated implantation failure (RIF) patients . Design: Registered, computer generated randomized double blinded placebo-controlled clinical trial.setting: University affiliated Avicenna specialized center for fertility and repeated miscarriages Patient(s): 93consecutive, consenting unexplained RIF patients with no history of malignancy or any uncontrolled background disease who were undergoing ICSIET program. Intervention(s): 100 numbered, opaque envelopes were assigned in order that 50patients receive intrauterine G-CSF (Filgrastim,300 mg/0.5 mL) and the other 50 patients receive 0.5 mL of normal saline as placebo. Main Outcome Measure(s): To determine clinical &ongoing pregnancy rates, rates in each group. Results: Statistical models assessing GCSF effect on implantation rates demonstrated no effect of GCSF treatment. Clinical and ongoing pregnancy rates were non-significantly higher and first trimester abortion rate was non-significantly lower in the GCSF group. No adverse side effectwas seen in both groups. Conclusions: In our study, intrauterine G-CSF did not effect on implantation rates. There was a non- significant improvement in clinical and ongoing pregnancy and reduction first trimester abortion in unexplained RIF patients (with normal endometrial thickness). Non significantly higher ongoing pregnancy and lower abortion rates in the GCSF group may be due to limited sample size or low GCSF dosage .So further multicenter studies with larger sample size or higher doses of GCSFis recommended. Clinical Trial Registration Number: IRCT2013063011653N2 Key Words: GCSF, pregnancy rate, ongoing pregnancy rate, randomized controlled trial

نویسندگان

Soheila Ansaripour

Avicenna specialiiazed center for fertility and repeated misscarrages(OB & GYN , Infertility fellowship),

Atousa Karimi

Avicenna specialiiazed center for fertility and repeated misscarrages(OB & GYN , Infertility fellowship),

Sara Mokhtar

Avicenna specialiiazed center for fertility and repeated misscarrages(OB & GYN , Infertility fellowship),

Mohammad Reza Sadeghi

Head & Research Deputy of Avicenna Research Institute