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G-CSF and PRP in Patients With Recurrent Implantation Failure

Primary Purpose

Infertility,Female

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Granulocyte colony-stimulating factor and platelet-rich plasma group
Control group
Sponsored by
Riyadh Fertility and Reproductive Health center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility,Female focused on measuring IVF, Platelet-rich plasma, Granulocyte colony-stimulating factor, Recurrent implantation failure

Eligibility Criteria

1 Year - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Riyadh Fertility and Reproductive Health centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Granulocyte colony-stimulating factor and platelet-rich plasma

Control group

Arm Description

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Gestational sac detected by ultrasound examination

Secondary Outcome Measures

Full Information

First Posted
May 27, 2020
Last Updated
June 1, 2020
Sponsor
Riyadh Fertility and Reproductive Health center
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1. Study Identification

Unique Protocol Identification Number
NCT04411212
Brief Title
G-CSF and PRP in Patients With Recurrent Implantation Failure
Official Title
Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riyadh Fertility and Reproductive Health center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility,Female
Keywords
IVF, Platelet-rich plasma, Granulocyte colony-stimulating factor, Recurrent implantation failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Granulocyte colony-stimulating factor and platelet-rich plasma
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Granulocyte colony-stimulating factor and platelet-rich plasma group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Gestational sac detected by ultrasound examination
Time Frame
Five weeks after embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usama M Fouda, Prof.
Phone
+0201095401375
Email
umfrfouda@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, Prof.
Organizational Affiliation
Riyadh Fertility and Reproductive Health center
Official's Role
Study Chair
Facility Information:
Facility Name
Riyadh Fertility and Reproductive Health center
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, Prof.
Phone
+201095401375
Email
umfrfouda@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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G-CSF and PRP in Patients With Recurrent Implantation Failure

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