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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03945812
Recruitment Status Recruiting
First Posted May 10, 2019
Last update posted July 21, 2020
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.
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. - 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
|Active Comparator: Granulocyte Colony Stimulating Factor Arm
Women in this group will receive G-CSF with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer cycle will be performed.
Drug: Granulocyte Colony Stimulating Factor
Filgrastim, Amgen, California, USA 300 mg/1.0 mL
|Active Comparator: Platelet Rich Plasma Arm
Women in this group will receive PRP with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer cycle will be performed.
Other: Platelet Rich Plasma Arm
Platelet Rich Plasma Arm
|Placebo Comparator: Saline
Women in this group will receive saline with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer cycle will be performed.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- All women aged 20-40 years
- BMI < 30 - Normal endometrial cavity confirmed by hysteroscopy Exclusion Criteria: - History of anti-phospholipid syndrome confirmed by serological tests. - History of any hematological and immunological disorders - History of chromosomal or genetic abnormalities in the patient or in the family - Any uterine abnormalities (congenital or acquired) - Previous uterine surgeries except caesarean section - Hypersensitivity to G-CSF - Uncontrolled systemic disease
Contact: Emad RH Issak, Dip 00201272228989 firstname.lastname@example.org
Wael El-Banna Clinic
Wael Elbanna Clinic
National Research Center, Egypt
Study Director: Emad RH Issak, Dip ClinAmygate
Mehrafza M, Kabodmehri R, Nikpouri Z, Pourseify G, Raoufi A, Eftekhari A, Samadnia S, Hosseini A. Comparing the Impact of Autologous Platelet-rich Plasma and Granulocyte Colony Stimulating Factor on Pregnancy Outcome in Patients with Repeated Implantation Failure. J Reprod Infertil. 2019 Jan-Mar;20(1):35-41.
Coughlan C, Ledger W, Wang Q, Liu F, Demirol A, Gurgan T, Cutting R, Ong K, Sallam H, Li TC. Recurrent implantation failure: definition and management. Reprod Biomed Online. 2014 Jan;28(1):14-38. doi: 10.1016/j.rbmo.2013.08.011. Epub 2013 Sep 14. Review.
Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.