Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The rationale behind this current study is to assess the impact of using PRP versus GCSF on
      the outcomes of frozen embryo transfer in term of clinical pregnancy rates.
    

Detailed description: 
      INTRODUCTION AND STUDY RATIONALE Despite the advancements in the treatment of infertility,
      repeated failure of implantation continues as a challenging difficulty.

      Embryo implantation is affected by many factors. Many efforts were made to improve the
      implantation rate by different methods blastocyst transfer, assisted hatching,
      preimplantation genetic screening, hysteroscopy, removal of hydrosalpinges and endometrial
      scratch. Furthermore, infertility specialists suggested some empirical methods like the
      infusion in the uterine cavity of platelet-rich plasma (PRP) in patients with thin
      endometrium which has been shown to be effective in improving the pregnancy rate.

      Another factor is granulocyte colony stimulating factor (G-CSF) which has receptors in
      endometrial cells and may have a role in implantation. The use of G-CSF in assisted
      reproductive technology (ART) has been tried by many research studies either via intrauterine
      or systemic administration.

      There is only one study compared the impact of PRP and GCSF administration on the pregnancy
      rate and on the endometrial thickness with a small sample size.

      The rationale behind this current study is to assess the impact of using PRP versus GCSF on
      the outcomes of frozen embryo transfer in term of clinical pregnancy rates.

      STUDY OBJECTIVES

      Primary:

      The primary objective of the study is to compare the clinical pregnancy rate determined by
      presence of fetal heart beat in transvaginal ultrasound after embryo transfer in all groups.

      Secondary:

      To compare the following in the three study arms:

        -  Chemical pregnancy determined by positive serum β-HCG, 2 weeks after embryo transfer.

        -  Clinical pregnancy rate adjusted by the endometrial thickness (thin versus normal) in
           all groups.

        -  Clinical pregnancy rate adjusted by PGS in all groups

        -  The midluteal endometrial thickness in all groups (histopathology & TVUS).

        -  The number of women who had thin endometrium and reaches endometrial thickness ≥ 7 mm
           after using G-CSF or PRP.

        -  Implantation rate

        -  Miscarriage rate

        -  Live-birth rate
    

Intervention name(s): Granulocyte Colony Stimulating Factor; Platelet Rich Plasma Arm; Saline
Intervention type(s): Drug; Other; Other
Intervention description(s): Filgrastim, Amgen, California, USA 300 mg/1.0 mL; Platelet Rich Plasma Arm; Saline 9%
Other intervention name(s): Filgrastim; Saline 9%
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GCSF; PRP; Pregnancy