Recruitment

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