Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer

Study Overview
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Brief Summary
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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
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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

Official Title
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The Impact of Using Granulocyte Colony Stimulating Factor (G-CSF) Versus Platelet Rich Plasma (PRP) on the Outcomes of Frozen Embryo Transfer; Randomized Controlled Study

Conditions
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Infertility

Intervention / Treatment
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* Drug: Granulocyte Colony Stimulating Factor
* Other: Platelet Rich Plasma Arm
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women aged 20-40 years non-smoker BMI < 30 Normal endometrial cavity confirmed by hysteroscopy Visiting the center for IVF by frozen embryo transfer during the period of the study 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Granulocyte Colony Stimulating Factor Arm<br>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 will be performed. | Drug: Granulocyte Colony Stimulating Factor<br>* Filgrastim, Amgen, California, USA 300 mg/1.0 mL<br>* Other names: Filgrastim;|
| Active Comparator: Platelet Rich Plasma Arm<br>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 will be performed. | Other: Platelet Rich Plasma Arm<br>* Platelet Rich Plasma Arm<br>|
| Placebo Comparator: Saline<br>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 will be performed. | Other: Saline<br>* Saline 9%<br>* Other names: Saline 9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical pregnancy rate | The clinical pregnancy rate | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical pregnancy rate | Chemical pregnancy rate | Up to 2 weeks | 
| endometrial thickness | endometrial thickness in all groups (histopathology & TVUS) | Up to 2 weeks | 
| Implantation rate | Implantation rate | Up to 2 weeks | 
| Miscarriage rate | Miscarriage rate | With second trimester | 
| Live-birth rate | Live-birth rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GCSF, PRP, Pregnancy