G-CSF and PRP in Patients With Recurrent Implantation Failure

Infertility,Female Clinical Trial

Official title:

Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411212
• Other study ID #: G-CSF and PRP in RIF
• Status: Recruiting
• Phase: Phase 2
• Start date: May 28, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: May 2020
• Source: Riyadh Fertility and Reproductive Health center
• Contact: Usama M Fouda, Prof.
• Phone: +0201095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 1 Year to 35 Years

Eligibility

Inclusion Criteria:

• Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred

Exclusion Criteria:

• Endometriosis

• Uterine anomalies

• Asherman syndrome

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility,Female

Intervention

Drug:
• Granulocyte colony-stimulating factor and platelet-rich plasma group
Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300µg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.

Other:
• Control group
Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.

Locations

Country	Name	City	State
Egypt	Riyadh Fertility and Reproductive Health center	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Fertility and Reproductive Health center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Gestational sac detected by ultrasound examination	Five weeks after embryo transfer