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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945812
• Other study ID #: INDV-0909012
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: March 8, 2023

Study information

• Verified date: October 2023
• Source: Wael Elbanna Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: March 8, 2023
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Granulocyte Colony Stimulating Factor
Filgrastim, Amgen, California, USA 300 mg/1.0 mL

Other:
• Platelet Rich Plasma Arm
Platelet Rich Plasma Arm
• Saline
Saline 9%

Locations

Country	Name	City	State
Egypt	Hayat center	Maadi	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Wael Elbanna Clinic	National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Rinehart J. Recurrent implantation failure: definition. J Assist Reprod Genet. 2007 Jul;24(7):284-7. doi: 10.1007/s10815-007-9147-4. Epub 2007 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical pregnancy rate	The clinical pregnancy rate	Up to 2 weeks
Secondary	Chemical pregnancy rate	Chemical pregnancy rate	Up to 2 weeks
Secondary	endometrial thickness	endometrial thickness in all groups (histopathology & TVUS)	Up to 2 weeks
Secondary	Implantation rate	Implantation rate	Up to 2 weeks
Secondary	Miscarriage rate	Miscarriage rate	With second trimester
Secondary	Live-birth rate	Live-birth rate	1 year