G-CSF and PRP in Patients With Recurrent Implantation Failure

June 1, 2020 updated by: Riyadh Fertility and Reproductive Health center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Riyadh Fertility and Reproductive Health center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control group
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.
ACTIVE_COMPARATOR: Granulocyte colony-stimulating factor and platelet-rich plasma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: Five weeks after embryo transfer
Gestational sac detected by ultrasound examination
Five weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Fertility and Reproductive Health center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 28, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (ACTUAL)

June 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-CSF and PRP in RIF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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