Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
-
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Other Names:
|
| 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
|
| 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. |
Other: Saline
Saline 9%
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The clinical pregnancy rate [Up to 2 weeks]
The clinical pregnancy rate
Secondary Outcome Measures
- Chemical pregnancy rate [Up to 2 weeks]
Chemical pregnancy rate
- endometrial thickness [Up to 2 weeks]
endometrial thickness in all groups (histopathology & TVUS)
- Implantation rate [Up to 2 weeks]
Implantation rate
- Miscarriage rate [With second trimester]
Miscarriage rate
- Live-birth rate [1 year]
Live-birth rate
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wael El-Banna Clinic | Maadi | Cairo | Egypt |
Sponsors and Collaborators
- Wael Elbanna Clinic
- National Research Centre, Egypt
Investigators
- Principal Investigator: Wael SS Elbanna, Consultant, Wael Elbanna Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Rinehart J. Recurrent implantation failure: definition. J Assist Reprod Genet. 2007 Jul;24(7):284-7. Epub 2007 Aug 3. Review.
- INDV-0909012