Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Infertility
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 40 years
- Gender
- Only males
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 ...
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 ?-HCG, 2 weeks after embryo transfer. Clinical pregnancy rate adjusted by the endometrial thickness (thin versus normal) 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
Tracking Information
- NCT #
- NCT03945812
- Collaborators
- Wael Elbanna Clinic
- National Research Centre, Egypt
- Investigators
- Study Director: Emad RH Issak, Dip ClinAmygate