Treatment of patients with recurrent pregnancy loss

Phase 2

Conditions: Recurrent pregnancy loss.
Habitual aborter

Registration Number: IRCT2013012211430N3

Lead Sponsor: Reaserch center of Avicenna

Brief Summary: Objective Endometrium undergoes several changes in structure and cellular compose during pregnancy. GCS-F (Granulocyte Colony-stimulating Factor) is an important cytokine with critical role in embryo implantation and pregnancy. The previous studies showed that that transvaginal endometrial perfusion with G-CSF might be helpful for improvement of implantation rate among patients with thin endometrium and repeated implantation failure (RIF). The aim of present study was to evaluate the impact of intrauterine injection of G-CSF in patients that suffering from unexplained recurrent miscarriage (RM). Materials and Methods In present randomized clinical trial a total of 68 patients were randomly allocated into two study groups including intrauterine G-CSF(300µg, Filgrastim, Switzerland) injection and control group (no G-CSF injection).All patients were in I/O (Ovulation Induction) cycle. In G-CSF group, intrauterine injection of G-CSF was done twice in cycle. All enrolled patients were under 40 years old and had at least two times unexplained pregnancy loss. Pregnancy was evaluated by titer of ßhCG, presence of gestational sac (implantation) was assessed by vaginal ultrasonography and finally clinical pregnancy was confirmed by detection of fetal heart rate (FHR). Results Eighteen out of 68 patients were excluded from the final analysis due to different reasons. No significant difference were observed between two study groups when we compared the rate of chemical pregnancy (26.1% vs. 29.6%, P=1.000), implantation (26.1% vs. 22.2%, Fisher’s exact test P=0.673), clinical pregnancy (17.4% vs. 11.1%, Fisher’s exact test P: 0.657) and abortion (8.7% vs. 18.5% Fisher’s exact test P=0.921). Conclusion In contrast to possible effect of G-CSF on improvement of implantation rate that revealed by some other studies, based on the result of present study we couldn’t suggest intrauterine injection of G-CSF for improvement of clinical pregnancy rate and reduce of abortion among patients with unexplained RM. Further molecular biology studies are needed to clarify the mechanism in which G-CSF affects the pregnancy process.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 68

Inclusion Criteria

patients with 3 or more abortion or 2 consecutive abortion; under 40 years old; normal karyotype; normal uterus; without infectious or immunologic or endocrine or thrombotic disorders; normal thyroid function,TPO<=500; FSH<=10; LH=normal and FBS=normal.
Exclusion criteria: cancer and no acceptance to participate in the study.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abortion rate. Timepoint: 14 days after intervention- 3 months after intervention and 9 months after intervention. Method of measurement: Laboratory-ultrasonography.

Secondary Outcome Measures